FDA Product Code
FDA Product Code HGX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5160
510(k) Clearances — 253 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220596 | Wearable Breast Pump (Model S9) | Shenzhen TPH Technology Co., Ltd. | 2022-05-26 | Traditional | PDF ↗ |
| K212564 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2022-05-06 | Traditional | PDF ↗ |
| K212773 | ARDO Alyssa | Ardo Medical AG | 2022-04-15 | Traditional | PDF ↗ |
| K212955 | Fit Pro Breast Pump | Hygeia II Medical Group, Inc. | 2022-03-15 | Traditional | PDF ↗ |
| K211024 | Electric Breast Pump | Shantou Huihengqi Electronic Technology Co., Ltd. | 2022-02-11 | Traditional | PDF ↗ |
| K212180 | Wearable Breast Pump (Model S12) | Shenzhen TPH Technology Co., Ltd. | 2022-02-11 | Traditional | PDF ↗ |
| K213311 | Lucy Breast Pump | Willow Innovations, Inc. | 2022-02-09 | Traditional | PDF ↗ |
| K212884 | Electric breast pump | Dongguan Rongfeng Medical Co., Ltd. | 2022-01-20 | Traditional | PDF ↗ |
| K211755 | Electric Breast Pump | Zhejiang Carebao Co., Ltd. | 2021-12-01 | Traditional | PDF ↗ |
| K210124 | Synergy Gold (SG) Portable (Models MM011450 and MM011460) | Uzinmedicare Co. | 2021-10-19 | Special | PDF ↗ |
| K202802 | TT Electric Breast Pump, TT Double Electric Breast Pump | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2021-08-26 | Traditional | PDF ↗ |
| K210936 | Elvie Stride | Chiaro Technology Limited | 2021-08-25 | Traditional | PDF ↗ |
| K210759 | Solo, Swing Maxi | Medela, LLC | 2021-08-11 | Traditional | PDF ↗ |
| K203148 | Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2021-07-08 | Traditional | PDF ↗ |
| K201152 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2021-05-04 | Traditional | PDF ↗ |
| K203570 | Mya Joy PLUS Breast Pump | Ameda, Inc. | 2021-04-22 | Traditional | PDF ↗ |
| K201903 | Electric breast pump (Models: RH-228 and RH-338) | Cixi Ruihong Electric Appliance Co., Ltd. | 2021-04-09 | Traditional | PDF ↗ |
| K202037 | imani i2 | Imani Co. | 2021-03-01 | Traditional | PDF ↗ |
| K202045 | imani i1 | Imani Co. | 2021-02-26 | Traditional | PDF ↗ |
| K200675 | Hi bebe super (Models BT-150S and BT-150L) | Bistos Co., Ltd. | 2021-02-10 | Special | PDF ↗ |
| K203383 | Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2020-12-15 | Special | PDF ↗ |
| K201381 | Philips Avent Single/Double electric breast pump Advanced | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2020-10-01 | Traditional | PDF ↗ |
| K193449 | Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2020-09-11 | Traditional | PDF ↗ |
| K200508 | Pump In Style | Medela, LLC | 2020-06-15 | Traditional | PDF ↗ |
| K200712 | Rumble Tuff Electric Breast Pump | A Cute Baby, Inc. | 2020-04-17 | Special | PDF ↗ |
| K192640 | Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump | Guangzhou Yongyi Industrial Co., Ltd. | 2020-03-30 | Traditional | PDF ↗ |
| K200406 | Evolve Breast Pump | Hygeia II Medical Group, Inc. | 2020-03-18 | Special | PDF ↗ |
| K191109 | Spectra Q | Uzinmedicare Co. | 2020-01-22 | Traditional | PDF ↗ |
| K191802 | Electric Breast Pump | Ningbo Huiyoo Baby Products Co., Ltd. | 2020-01-16 | Traditional | PDF ↗ |
| K190465 | Evolve Breast Pump | Hygeia II Medical Group, Inc. | 2019-10-18 | Special | PDF ↗ |
| K191653 | Freestyle Flex | Medela AG | 2019-10-17 | Traditional | PDF ↗ |
| K191208 | Spectra Cashmere | Uzinmedicare Co. | 2019-10-11 | Special | PDF ↗ |
| K191577 | Willow Wearable Breast Pump 2.0 | Exploramed Nc7, Inc. | 2019-09-06 | Special | PDF ↗ |
| K190810 | OPERA, OPERA eco | Unimom.Co | 2019-08-30 | Traditional | PDF ↗ |
| K182749 | Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd. | 2019-06-12 | Traditional | PDF ↗ |
| K182413 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2019-03-07 | Traditional | PDF ↗ |
| K181784 | Spectra S3 Plus | Uzinmedicare Co. | 2018-11-30 | Traditional | PDF ↗ |
| K181937 | Pump In Style Advanced, Advanced Personal Double Breastpump | Medela, LLC | 2018-10-16 | Traditional | PDF ↗ |
| K181863 | Elvie Pump | Chiaro Technology Limited | 2018-10-10 | Traditional | PDF ↗ |
| K180075 | MINUET LCD, MINUET LCD eco | Unimom.Co | 2018-08-06 | Traditional | PDF ↗ |
| K172842 | GCE704 Breast Pump | Globalcare | 2018-06-18 | Traditional | PDF ↗ |
| K173699 | The Pump by Babyation | Babyation, LLC | 2018-04-04 | Traditional | PDF ↗ |
| K172989 | Electric Breast Pump | Joytech Healthcare Co. , Ltd. | 2017-12-20 | Traditional | PDF ↗ |
| K172067 | One Mum Pumpset | Ardo Medical AG | 2017-11-29 | Special | PDF ↗ |
| K172772 | Freemie Independence, Freemie Liberty | Dao Health | 2017-10-13 | Traditional | PDF ↗ |
| K163183 | Yooeehouse Breast Pump | Nantong Poly Technology Co., Ltd. | 2017-10-02 | Traditional | PDF ↗ |
| K170722 | Moxxly Flow Collection System | Moxxly, Inc. | 2017-08-28 | Traditional | PDF ↗ |
| K163136 | Youha electric breast pump | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2017-07-31 | Traditional | PDF ↗ |
| K162415 | Spectra 9Plus | Uzinmedicare Company | 2017-03-15 | Traditional | PDF ↗ |
| K162870 | CIMLRE F1 and CIMILRE S3 | Cimilre Co., Ltd. | 2017-03-07 | Traditional | PDF ↗ |
| K162747 | Proture Double Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2016-12-08 | Traditional | PDF ↗ |
| K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail | Medela, Inc. | 2016-10-28 | Traditional | PDF ↗ |
| K160274 | Hi bebe plus | Bistos Co., Ltd. | 2016-09-01 | Traditional | PDF ↗ |
| K161532 | Philips Avent Comfort Single/Twin Electric Breast Pump | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2016-08-29 | Traditional | PDF ↗ |
| K161266 | Athena Breast Pump | Exploramed Nc7, Inc. | 2016-08-11 | Traditional | PDF ↗ |
| K160511 | Naya Breast Pump System | Naya Health, Inc. | 2016-06-24 | Traditional | PDF ↗ |
| K150476 | Spectra S1Plus and Spectra S2 Plus | Uzinmedicare Co. | 2016-04-15 | Traditional | PDF ↗ |
| K151284 | Electric Double Breast Pumps | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2015-12-21 | Traditional | PDF ↗ |
| K150923 | Breast Pump | Guangzhou Jinxinbao Electronic Co., Ltd. | 2015-11-06 | Traditional | PDF ↗ |
| K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental | Medela AG | 2015-11-05 | Traditional | PDF ↗ |
| K150721 | ARDO Calypso Pro Powered Breast Pump | Ardo Medical AG | 2015-06-17 | Traditional | PDF ↗ |
| K143585 | Electric Breast Pump | Shantou Xinghe Electrical Apparatuses Co., Ltd. | 2015-05-06 | Traditional | PDF ↗ |
| K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty | Medela AG | 2015-04-21 | Traditional | PDF ↗ |
| K143574 | Melodi Prime Breast Pump | Genadyne Biotechnologies, Inc. | 2015-04-21 | Traditional | PDF ↗ |
| K142479 | MEGNA BREAST PUMPS | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2015-02-24 | Traditional | PDF ↗ |
| K132220 | PJ'S SERENITY | Limerick, Inc. | 2015-02-20 | Traditional | PDF ↗ |
| K142168 | NATURE'S BOND 600 AND NATURE'S BOND 603 | Devon Medical Products, Inc. | 2014-12-04 | Traditional | PDF ↗ |
| K141742 | ARDO CARUM AND CALYPSO POWERED BREAST PUMPS | Ardo Medical AG | 2014-10-17 | Traditional | PDF ↗ |
| K132882 | ELECTRIC BREAST PUMP | Shantou Xinghe Electrical Apparatuses Co., Ltd. | 2014-04-24 | Traditional | PDF ↗ |
| K130349 | FREEMIE BREAST COLLECTION SYSTEM | Dao Health | 2013-09-06 | Traditional | PDF ↗ |
| K131153 | EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP | Evenflo Feeding Incorporated | 2013-06-18 | Traditional | PDF ↗ |
| K131027 | MEMORY PUMP MODEL Y4947 | Tomy International | 2013-05-30 | Traditional | PDF ↗ |
| K121478 | NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP | Mapa GmbH | 2013-04-05 | Traditional | PDF ↗ |
| K122474 | LANSINOH POWERED ELECTRIC BREAST PUMP | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012-12-28 | Special | PDF ↗ |
| K113315 | RUMBLE TUFF | Acute Ideas Co. , Ltd. | 2012-11-20 | Traditional | PDF ↗ |
| K121322 | CLOSER TO NATURE | Mayborn Group Limited | 2012-05-31 | Traditional | PDF ↗ |
| K112856 | LUCINA-MELODI | Genadyne Biotechnologies, Inc. | 2012-05-10 | Traditional | PDF ↗ |
| K113664 | CLOSER TO NATURE ELECTRIC BREAST PUMP | Mayborn Group Limited | 2012-02-17 | Traditional | PDF ↗ |
| K111411 | FREEMIE (R) | Dao Health | 2012-02-01 | Traditional | PDF ↗ |
| K102516 | LUCINA MODEL MELODI | Genadyne Biotechnologies, Inc. | 2011-08-11 | Traditional | PDF ↗ |
| K110343 | TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP | Mayborn Baby and Child / Jackel International, Ltd. | 2011-03-11 | Traditional | PDF ↗ |
| K102600 | SIMPLYGO BREAST PUMP | Evenflo Company, Inc. | 2010-12-22 | Special | PDF ↗ |
| K101157 | E-BASIC SINGLE BREAST PUMP | Mapa GmbH | 2010-09-17 | Traditional | PDF ↗ |
| K093145 | SPECTRA SERIES BREAST PUMP | Uzinmedicare Co. | 2010-08-13 | Traditional | PDF ↗ |
| K093648 | SIMPLISSE ELECTRIC BREASTFEEDING COMPANION | Simplisse, Inc. | 2010-07-14 | Traditional | PDF ↗ |
| K100929 | UNIMOM ALLEGRO | Blue Egg CO | 2010-06-16 | Traditional | PDF ↗ |
| K100435 | AMEDA PLATINUM BREAST PUMP | Evenflo Company, Inc. | 2010-05-28 | Traditional | PDF ↗ |
| K100385 | NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP | Luv N' Care, Ltd. | 2010-03-24 | Traditional | PDF ↗ |
| K092783 | DEBP | Enko , Ltd. | 2009-10-22 | Traditional | PDF ↗ |
| K092770 | SIMPLYGO HANDS FREE BREAST PUMP | Evenflo Company, Inc. | 2009-10-09 | Special | PDF ↗ |
| K081463 | MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP | Medel S.P.A. | 2009-02-06 | Abbreviated | PDF ↗ |
| K081932 | ENDEARE BREAST PUMP | Hygeia Medical, Inc. | 2009-01-22 | Traditional | PDF ↗ |
| K082802 | MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B | Learning Curve Brands Inc. the First Years | 2008-10-09 | Traditional | PDF ↗ |
| K082307 | EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT | Evenflo Company, Inc. | 2008-09-11 | Special | PDF ↗ |
| K070435 | DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400 | Whittlestone, Inc. | 2007-07-17 | Traditional | PDF ↗ |
| K061013 | PLAYTEX EMBRACE PETITE BREAST PUMP | Playtex Products, Inc. | 2006-08-15 | Traditional | PDF ↗ |
| K053052 | MEDELA SWING BREAST PUMP | Medela AG | 2006-05-02 | Traditional | PDF ↗ |
| K051926 | LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP | Limerick, Inc. | 2005-12-12 | Traditional | PDF ↗ |
| K052909 | EVENFLO ELAN BREAST PUMP | Evenflo Company, Inc. | 2005-11-01 | Traditional | PDF ↗ |
| K052047 | ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 | Avent America, Inc. | 2005-09-22 | Traditional | PDF ↗ |
Product code HGX · Class II · Obstetrics/Gynecology. Data: openFDA.