FDA Product Code
FDA Product Code MLR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6860
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. | 2026-04-15 | Traditional | PDF ↗ |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. | 2025-04-14 | Traditional | PDF ↗ |
| K231893 | LOWTEM Crystal 120 | Lowtem Co., Ltd. | 2024-09-18 | Traditional | PDF ↗ |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077) | Advanced Sterilization Products | 2024-07-05 | Traditional | PDF ↗ |
| K233762 | SteroScope® Sterilization Technology System | Ideate Medical, Inc. | 2024-06-27 | Traditional | PDF ↗ |
| K233065 | V-PRO maX 2 Low Temperature Sterilization System | Steris | 2023-10-20 | Special | PDF ↗ |
| K223476 | V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation | 2023-08-07 | Traditional | PDF ↗ |
| K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | 2023-05-25 | Special | PDF ↗ |
| K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette | Plasmapp Co,., Ltd. | 2023-05-09 | Traditional | PDF ↗ |
| K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | 2023-04-14 | Traditional | PDF ↗ |
| K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System | Steris | 2022-09-09 | Special | PDF ↗ |
| K220404 | STERRAD NX with ALLClear Technology | Advanced Sterilization Products, Inc. | 2022-05-16 | Traditional | PDF ↗ |
| K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | Plasmapp Co,., Ltd. | 2021-10-22 | Traditional | PDF ↗ |
| K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | Advanced Sterilization Products, Inc. | 2021-10-09 | Traditional | PDF ↗ |
| K190005 | Sterilucent HC 80TT Hydrogen Peroxide Sterilizer | Sterilucent, Inc. | 2019-09-13 | Traditional | PDF ↗ |
| K190917 | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems | STERIS Corporation | 2019-05-09 | Special | PDF ↗ |
| K190103 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System | STERIS Corporation | 2019-04-05 | Special | PDF ↗ |
| K182568 | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | STERIS Corporation | 2019-01-03 | Traditional | PDF ↗ |
| K172754 | V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation | 2018-02-09 | Traditional | PDF ↗ |
| K172319 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | STERIS Corporation | 2018-01-18 | Traditional | PDF ↗ |
| K162413 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | STERIS Corporation | 2017-03-31 | Traditional | PDF ↗ |
| K162007 | STERRAD NX Sterilizer | Advanced Sterilization Products | 2017-02-16 | Special | PDF ↗ |
| K160818 | STERRAD® NX Sterilizer with ALLClear Technology | Advanced Sterilization Products | 2016-09-27 | Traditional | PDF ↗ |
| K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | Advanced Sterilization Products | 2016-09-26 | Traditional | PDF ↗ |
| K160433 | V-PRO® 1 Plus and V-PRO® maX Low Temperature | STERIS Corporation | 2016-07-06 | Traditional | PDF ↗ |
| K151725 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Advanced Sterilization Products | 2016-01-13 | Traditional | PDF ↗ |
| K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Advanced Sterilization Products | 2015-04-03 | Traditional | PDF ↗ |
| K140464 | STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER | Sterilucent, Inc. | 2014-10-31 | Traditional | PDF ↗ |
| K140498 | V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM | STERIS Corporation | 2014-07-24 | Traditional | PDF ↗ |
| K131120 | AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | STERIS Corporation | 2013-07-16 | Traditional | PDF ↗ |
| K111377 | STERRAD(R) 100NX STERILIZER DUO CYCLE | Advanced Sterilization Products | 2012-09-13 | Traditional | PDF ↗ |
| K120632 | AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM | STERIS Corporation | 2012-06-26 | Traditional | PDF ↗ |
| K112813 | AMSCO V-PRO | Steris Corp | 2011-12-01 | Special | PDF ↗ |
| K112760 | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | STERIS Corporation | 2011-11-22 | Special | PDF ↗ |
| K111810 | AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS | STERIS Corporation | 2011-09-02 | Special | PDF ↗ |
| K102394 | AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM | STERIS Corporation | 2011-08-18 | Traditional | PDF ↗ |
| K102330 | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | STERIS Corporation | 2011-08-12 | Traditional | PDF ↗ |
| K092622 | STERRAD 100NX STERILIZER EXPRESS CYCLE | Advanced Sterilization Products | 2011-03-04 | Traditional | PDF ↗ |
| K083097 | AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM | STERIS Corporation | 2009-08-03 | Traditional | PDF ↗ |
| K071385 | STERRAD 100NX STERILIZER | Advanced Sterilization Products | 2007-11-29 | Traditional | PDF ↗ |
| K062297 | VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM | STERIS Corporation | 2007-10-04 | Traditional | PDF ↗ |
| K042116 | STERRAD NX STERILIZER | Advanced Sterilization Products | 2005-04-22 | Traditional | PDF ↗ |
| K030429 | STERRAD 200 STERILIZER | Advanced Sterilization Products | 2003-08-18 | Traditional | PDF ↗ |
| K991999 | STERRAD 100S STERILIZER | Advanced Sterilization Products | 2000-06-15 | Traditional | PDF ↗ |
| K981625 | STERRAD 50 STERILIZER | Advanced Sterilization Products | 1999-01-11 | Traditional | PDF ↗ |
| K943654 | HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS | Mdt Biologic Co. | 1995-08-02 | Traditional | PDF ↗ |
| K924380 | MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE | Mdt Corp., Inc. | 1994-02-16 | Traditional | PDF ↗ |
Product code MLR · Class II · General Hospital. Data: openFDA.