Oximeter, Reprocessed
FDA product code NLF · Class II (moderate risk) · 21 CFR 870.2700 · Cardiovascular
same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
27510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Sterilmed, Inc. 4
- Renu Medical, Inc. 4
- Clearmedical, Inc. 3
- Hygia Health Services, Inc. 3
- Stryker Sustainability Solutions 3
- Vanguard Medical Concepts, Inc. 2
- Masimo Corporation 2
- Nellcor Puritan Bennett, Inc. 1
- Datex-Ohmeda, Inc. 1
- Ascent Healthcare Solutions 1
- Midwest Reprocessing Center, LLC 1
- Surgical Instrument Service and Savings, Inc. 1
- Surgical Instrument and Savings Inc (Dba Medline Renewal) 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…NLF · Traditional | Stryker Sustainability Solutions | 10/22/2024SE |
| K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…NLF · Traditional | Stryker Sustainability Solutions | 12/04/2022SE |
| K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L)…NLF · Traditional | Stryker Sustainability Solutions | 03/08/2022SE |
| K201699 | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorNLF · Special | Surgical Instrument and Savings Inc (Dba Medline… | 07/22/2020SE |
| K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsNLF · Traditional | Surgical Instrument Service and Savings, Inc. | 07/03/2019SE |
| K111773 | Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and NeonateNLF · Traditional | Renu Medical, Inc. | 11/16/2011SE |
| K110723 | M-Lncs Oximetry Sensors, Reprocessed M-Lncs Oximetry SensorsNLF · Special | Masimo Corporation | 07/28/2011SE |
| K102560 | Reprocessed Pulse Oximeter SensorsNLF · Traditional | Sterilmed, Inc. | 02/18/2011SE |
| K101280 | Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeNLF · Traditional | Midwest Reprocessing Center, LLC | 10/07/2010SE |
| K092368 | Reprocessed Pulse Oximeter SensorsNLF · Traditional | Sterilmed, Inc. | 11/03/2009SE |
| K083719 | LNCS Oximetry SensorsNLF · Traditional | Masimo Corporation | 07/30/2009SE |
| K081927 | Renu Medical Oximetry Sensor, Adult, Ped, Inf,NeoNLF · Traditional | Renu Medical, Inc. | 02/06/2009SE |
| K081238 | Reprocessed Masimo Pulse Oximeter SensorsNLF · Traditional | Ascent Healthcare Solutions | 07/29/2008SE |
| K080424 | Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…NLF · Traditional | Hygia Health Services, Inc. | 05/28/2008SE |
| K072194 | Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25NLF · Traditional | Renu Medical, Inc. | 11/29/2007SE |
| K063661 | Renu Reprocessed Nellcor Oxysensor, Models D-20 and I-20NLF · Traditional | Renu Medical, Inc. | 05/25/2007SE |
| K042891 | Datex-Ohmeda Oxy-Afr SensorNLF · Traditional | Datex-Ohmeda | 06/29/2005SE |
| K042316 | Vanguard Reprocessed Pulse Oximeter SensorsNLF · Traditional | Vanguard Medical Concepts, Inc. | 01/06/2005SE |
| K033973 | Oxisensor II Recycled Sensor and Oximax Recycled SensorNLF · Traditional | Nellcor Puritan Bennett, Inc. | 12/13/2004SE |
| K041127 | Modification to: Reprocessed Oximax Pulse Oximeter SensorsNLF · Traditional | Sterilmed, Inc. | 09/23/2004SE |
| K041867 | Hygia Health Services Reprocessed Oximax Sensors Model # Hhs-Max-A, Hhs-Max-Al, Hhs-Max-NNLF · Traditional | Hygia Health Services, Inc. | 09/10/2004SE |
| K012715 | Hygia Health Services Reprocessed Nellcot D-25 Oxisensor IINLF · Traditional | Hygia Health Services, Inc. | 08/01/2003SE |
| K012677 | Reprocessed Pulse Oximeter SensorsNLF · Traditional | Sterilmed, Inc. | 03/28/2003SE |
| K012344 | Vanguard Reprocessed Pulse Oximeter SensorsNLF · Traditional | Vanguard Medical Concepts, Inc. | 10/04/2002SE |
| K012622 | Clearmedical/Nellcor Oxisensor II, Pediatric, Model D-20NLF · Traditional | Clearmedical, Inc. | 07/03/2002SE |
| K012609 | Clearmedical/Nellcor Oxisensor II, Neonatal/Adult, Model N-25NLF · Traditional | Clearmedical, Inc. | 07/03/2002SE |
| K012600 | Clearmedical/Nellcor Oxisensor II, Adult, Model D-25/D-25LNLF · Traditional | Clearmedical, Inc. | 07/03/2002SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1683-2008 | Infant 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | Ascent Healthcare Solutions, Inc. | 03/11/2008Terminated |
| Z-1664-2008 | Adult 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | Ascent Healthcare Solutions, Inc. | 03/11/2008Terminated |
| Z-1663-2008 | Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device --…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | Ascent Healthcare Solutions, Inc. | 03/11/2008Terminated |