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 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K051112 | WHITTLESTONE EXPRESSER | Whittlestone, Inc. | 2005-09-07 | Traditional | PDF ↗ |
| K051413 | ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 | Avent America, Inc. | 2005-08-29 | Traditional | PDF ↗ |
| K043098 | GERBER DOUBLE ELECTRIC BREAST PUMP | Gerber Products Co. | 2004-12-15 | Traditional | PDF ↗ |
| K033131 | NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 | The First Years, Inc. | 2003-10-30 | Special | PDF ↗ |
| K032566 | NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP | The First Years, Inc. | 2003-09-15 | Special | PDF ↗ |
| K031614 | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP | Medela, Inc. | 2003-06-06 | Traditional | PDF ↗ |
| K021739 | LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 | Limerick, Inc. | 2003-01-10 | Traditional | PDF ↗ |
| K022933 | EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT | Evenflo Company, Inc. | 2002-12-02 | Traditional | PDF ↗ |
| K022594 | PLAYTEX BREAST PUMP | Playtex Products, Inc. | 2002-11-01 | Traditional | PDF ↗ |
| K022140 | WHISPER WEAR BREAST PUMP | Whisper Wear | 2002-09-30 | Traditional | PDF ↗ |
| K020375 | THE NURTURE III BREAST PUMP | Bailey Medical Engineering | 2002-05-03 | Traditional | PDF ↗ |
| K020518 | MEDELA SYMPHONY BREAST PUMP, MODEL 024 | Medela, Inc. | 2002-03-07 | Traditional | PDF ↗ |
| K012275 | PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP | Limerick, Inc. | 2002-01-07 | Traditional | PDF ↗ |
| K002696 | WHITTLESTONE BREASTPUMP | Whittlestone, Inc. | 2001-03-21 | Traditional | PDF ↗ |
| K981549 | LACTATION TECHNIQUES MODEL B | Lactation Techniques, Inc. | 1999-05-24 | Traditional | PDF ↗ |
| K983776 | EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP | Evenflo Co., Inc. | 1999-04-26 | Traditional | PDF ↗ |
| K973501 | EXPRESSE AND PREMIER POWERED BREAST PUMPS | Ameda Medizintechnik AG | 1997-12-11 | Traditional | PDF ↗ |
| K970488 | HYDROCHECK MICRO FILTER | White River Concepts | 1997-11-04 | Traditional | PDF ↗ |
| K971543 | LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP | Kaweco GmbH | 1997-09-18 | Traditional | PDF ↗ |
| K964679 | WHITE RIVER AUTOMATIC BREAST PUMP | White River Concepts | 1997-06-10 | Traditional | PDF ↗ |
| K964396 | DOUBLE UP BREAST PUMP | The Natural Choice Co., Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K960727 | EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT | Evenflo Co., Inc. | 1997-02-14 | Traditional | PDF ↗ |
| K964403 | SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068) | The First Years, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K960726 | EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP | Evenflo Co., Inc. | 1996-07-22 | Traditional | PDF ↗ |
| K952712 | WHITE RIVER BATTERY-POWERED BREAST PUMP | Natural Technologies, Inc. | 1996-04-18 | Traditional | PDF ↗ |
| K950750 | MEDELAS BREAST PUMP | Medela, Inc. | 1995-10-16 | Traditional | PDF ↗ |
| K950531 | EGNELL ELITE | Hollister, Inc. | 1995-09-22 | Traditional | PDF ↗ |
| K942534 | GERBER NATURAL COMFORT BATTERY BREAST PUMP | Gerber Products Co. | 1995-05-25 | Traditional | PDF ↗ |
| K924312 | NURTURE III | Bailey Medical Engineering | 1995-05-11 | Traditional | PDF ↗ |
| K941112 | SINGLE HANDED BREAST PUMP | Macneil Baby Care , Ltd. | 1995-01-30 | Traditional | PDF ↗ |
| K936309 | DELUXE MAGMAG BREAST PUMP | Pigeon Corp. | 1994-11-30 | Traditional | PDF ↗ |
| K935249 | ADVANCED MAGMAG AC/BATTERY BREAST PUMP | Pigeon Corp. | 1994-11-22 | Traditional | PDF ↗ |
| K921261 | ELECTRIC POWERED BREAST PUMP | Schuco, Inc. | 1993-11-09 | Traditional | PDF ↗ |
| K901344 | MEDELA BATTERY OPERATED BREAST PUMP | Medela, Inc. | 1990-08-06 | Traditional | PDF ↗ |
| K895114 | FRANK MILK PUMP | Buttner-Frank GmbH | 1990-03-05 | Traditional | PDF ↗ |
| K893545 | IVEX MODEL NO. BP 3000 BREASTPUMP | Ivex Medical, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K891996 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP | Gerber Products Co. | 1989-08-07 | Traditional | PDF ↗ |
| K890588 | GENTLE EXPRESSIONS ELECTRIC BREAST PUMP | Healthteam | 1989-05-16 | Traditional | PDF ↗ |
| K875300 | MEDELA BREAST-PUMP LACTINA | Medela, Inc. | 1988-04-06 | Traditional | PDF ↗ |
| K874071 | MOTHER'S MILK BAG | Yanase Waitch K.K. | 1987-12-08 | Traditional | PDF ↗ |
| K861513 | LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP | Crystal Medical Products, Inc. | 1986-08-08 | Traditional | PDF ↗ |
| K853326 | WATER DRIVEN BREAST PUMP BY BABY NURSE | Baby Nurse | 1985-11-19 | Traditional | PDF ↗ |
| K853107 | AXICARE CM-14 AUTOMATIC BREAST PUMP | Crystal Medical Products, Inc. | 1985-11-19 | Traditional | PDF ↗ |
| K852460 | GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY | Healthteam | 1985-11-14 | Traditional | PDF ↗ |
| K850705 | THE WHITE RIVER PORTA-ELEC-BREAST PUMP | Natural Technologies, Inc. | 1985-07-11 | Traditional | PDF ↗ |
| K850753 | NATURAL MOTHER BREAST PUMP | Crystal Medical Products, Inc. | 1985-06-07 | Traditional | PDF ↗ |
| K844013 | CARE ELECTRIC BREAST PUMP | Hankscraft Div. of Gerber Products Co. | 1985-02-15 | Traditional | PDF ↗ |
| K844307 | EGNELL-LACT B BATTERY-OPERATED BREAST PUMP | Egnell, Inc. | 1985-02-04 | Traditional | PDF ↗ |
| K842766 | CRYSTAL MEDICAL MILK COLLECTION KIT | Crystal Medical Products, Inc. | 1984-09-25 | Traditional | PDF ↗ |
| K811403 | AXICARE BREAST PUMP MODEL | Neonatal Corp. | 1981-06-12 | Traditional | PDF ↗ |
| K810065 | SCOTT CM42 PASTEURIZER | William Harvey Life Products Corp. | 1981-01-28 | Traditional | PDF ↗ |
| K801862 | MEDELA ELECTRIC BREAST PUMP | Medela, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K801246 | OXFORD HUMAN MILK PASTEURISER | Vickers America Medical Corp. | 1980-10-03 | Traditional | PDF ↗ |
Product code HGX · Class II · Obstetrics/Gynecology. Data: openFDA.