FDA Product Code
FDA Product Code NLF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2700
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) | Stryker Sustainability Solutions | 2024-10-22 | Traditional | PDF ↗ |
| K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) | Stryker Sustainability Solutions | 2022-12-04 | Traditional | PDF ↗ |
| K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I) | Stryker Sustainability Solutions | 2022-03-08 | Traditional | PDF ↗ |
| K201699 | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor | Surgical Instrument and Savings Inc (Dba Medline Renewal) | 2020-07-22 | Special | PDF ↗ |
| K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | Surgical Instrument Service and Savings, Inc. | 2019-07-03 | Traditional | PDF ↗ |
| K111773 | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE | Renu Medical, Inc. | 2011-11-16 | Traditional | PDF ↗ |
| K110723 | M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS | Masimo Corporation | 2011-07-28 | Special | PDF ↗ |
| K102560 | REPROCESSED PULSE OXIMETER SENSORS | Sterilmed, Inc. | 2011-02-18 | Traditional | PDF ↗ |
| K101280 | MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE | Midwest Reprocessing Center, LLC | 2010-10-07 | Traditional | PDF ↗ |
| K092368 | REPROCESSED PULSE OXIMETER SENSORS | Sterilmed, Inc. | 2009-11-03 | Traditional | PDF ↗ |
| K083719 | LNCS OXIMETRY SENSORS | Masimo Corporation | 2009-07-30 | Traditional | PDF ↗ |
| K081927 | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO | Renu Medical, Inc. | 2009-02-06 | Traditional | PDF ↗ |
| K081238 | REPROCESSED MASIMO PULSE OXIMETER SENSORS | Ascent Healthcare Solutions | 2008-07-29 | Traditional | PDF ↗ |
| K080424 | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 | Hygia Health Services, Inc. | 2008-05-28 | Traditional | PDF ↗ |
| K072194 | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 | Renu Medical, Inc. | 2007-11-29 | Traditional | PDF ↗ |
| K063661 | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | Renu Medical, Inc. | 2007-05-25 | Traditional | PDF ↗ |
| K042891 | DATEX-OHMEDA OXY-AFR SENSOR | Datex-Ohmeda | 2005-06-29 | Traditional | PDF ↗ |
| K042316 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | Vanguard Medical Concepts, Inc. | 2005-01-06 | Traditional | PDF ↗ |
| K033973 | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR | Nellcor Puritan Bennett, Inc. | 2004-12-13 | Traditional | PDF ↗ |
| K041127 | MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS | Sterilmed, Inc. | 2004-09-23 | Traditional | PDF ↗ |
| K041867 | HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N | Hygia Health Services, Inc. | 2004-09-10 | Traditional | PDF ↗ |
| K012715 | HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II | Hygia Health Services, Inc. | 2003-08-01 | Traditional | PDF ↗ |
| K012677 | REPROCESSED PULSE OXIMETER SENSORS | Sterilmed, Inc. | 2003-03-28 | Traditional | PDF ↗ |
| K012344 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | Vanguard Medical Concepts, Inc. | 2002-10-04 | Traditional | PDF ↗ |
| K012622 | CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 | Clearmedical, Inc. | 2002-07-03 | Traditional | PDF ↗ |
| K012609 | CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 | Clearmedical, Inc. | 2002-07-03 | Traditional | PDF ↗ |
| K012600 | CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L | Clearmedical, Inc. | 2002-07-03 | Traditional | PDF ↗ |
Product code NLF · Class II · Cardiovascular. Data: openFDA.