NLF · Oximeter, Reprocessed
Cardiovascular · 21 CFR 870.2700 · Class 2
Overview
| Product Code | NLF |
|---|---|
| Device Name | Oximeter, Reprocessed |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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 | Oct 22, 2024 | SESE |
| 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 | Dec 4, 2022 | SESE |
| 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 | Mar 8, 2022 | SESE |
| K201699 | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor | Surgical Instrument and Savings Inc (Dba Medline Renewal) | Jul 22, 2020 | SESE |
| K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | Surgical Instrument Service and Savings, Inc. | Jul 3, 2019 | SESE |
| K111773 | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE | Renu Medical, Inc. | Nov 16, 2011 | SESE |
| K110723 | M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS | Masimo Corporation | Jul 28, 2011 | SESE |
| K102560 | REPROCESSED PULSE OXIMETER SENSORS | Sterilmed, Inc. | Feb 18, 2011 | SESE |
| K101280 | MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE | Midwest Reprocessing Center, LLC | Oct 7, 2010 | SESE |
| K092368 | REPROCESSED PULSE OXIMETER SENSORS | Sterilmed, Inc. | Nov 3, 2009 | SESE |
| K083719 | LNCS OXIMETRY SENSORS | Masimo Corporation | Jul 30, 2009 | SESE |
| K081927 | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO | Renu Medical, Inc. | Feb 6, 2009 | SESE |
| K081238 | REPROCESSED MASIMO PULSE OXIMETER SENSORS | Ascent Healthcare Solutions | Jul 29, 2008 | SESE |
| K080424 | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 | Hygia Health Services, Inc. | May 28, 2008 | SESE |
| K072194 | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 | Renu Medical, Inc. | Nov 29, 2007 | SESE |
| K063661 | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | Renu Medical, Inc. | May 25, 2007 | SESE |
| K042891 | DATEX-OHMEDA OXY-AFR SENSOR | Datex-Ohmeda | Jun 29, 2005 | SESE |
| K042316 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | Vanguard Medical Concepts, Inc. | Jan 6, 2005 | SESE |
| K033973 | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR | Nellcor Puritan Bennett, Inc. | Dec 13, 2004 | SESE |
| K041127 | MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS | Sterilmed, Inc. | Sep 23, 2004 | SESE |
Top Applicants
- Renu Medical, Inc. — 4 clearances
- Sterilmed, Inc. — 4 clearances
- Clearmedical, Inc. — 3 clearances
- Hygia Health Services, Inc. — 3 clearances
- Stryker Sustainability Solutions — 3 clearances
