Oximeter, Reprocessed
The Reprocessed Oximeter is a reprocessed cardiovascular monitoring device used to measure blood oxygen saturation non-invasively; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NLF and regulation 21 CFR 870.2700 in the Cardiovascular specialty (reviewed by the Anesthesiology panel). The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NLF
- Device Class
- FDA class 2
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 27 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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) | Oct 22, 2024 | Substantially Equivalent | Stryker Sustainability Solutions |
| 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) | Dec 04, 2022 | Substantially Equivalent | Stryker Sustainability Solutions |
| 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) | Mar 08, 2022 | Substantially Equivalent | Stryker Sustainability Solutions |
| K201699 | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor | Jul 22, 2020 | Substantially Equivalent | Surgical Instrument and Savings Inc (Dba Medline Renewal) |
| K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | Jul 03, 2019 | Substantially Equivalent | Surgical Instrument Service and Savings, Inc. |
| K111773 | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE | Nov 16, 2011 | Substantially Equivalent | Renu Medical, Inc. |
| K110723 | M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS | Jul 28, 2011 | Substantially Equivalent | Masimo Corporation |
| K102560 | REPROCESSED PULSE OXIMETER SENSORS | Feb 18, 2011 | Substantially Equivalent | Sterilmed, Inc. |
| K101280 | MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE | Oct 07, 2010 | Substantially Equivalent | Midwest Reprocessing Center, LLC |
| K092368 | REPROCESSED PULSE OXIMETER SENSORS | Nov 03, 2009 | Substantially Equivalent | Sterilmed, Inc. |
| K083719 | LNCS OXIMETRY SENSORS | Jul 30, 2009 | Substantially Equivalent | Masimo Corporation |
| K081927 | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO | Feb 06, 2009 | Substantially Equivalent | Renu Medical, Inc. |
| K081238 | REPROCESSED MASIMO PULSE OXIMETER SENSORS | Jul 29, 2008 | Substantially Equivalent | Ascent Healthcare Solutions |
| K080424 | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 | May 28, 2008 | Substantially Equivalent | Hygia Health Services, Inc. |
| K072194 | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 | Nov 29, 2007 | Substantially Equivalent | Renu Medical, Inc. |
| K063661 | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | May 25, 2007 | Substantially Equivalent | Renu Medical, Inc. |
| K042891 | DATEX-OHMEDA OXY-AFR SENSOR | Jun 29, 2005 | Substantially Equivalent | Datex-Ohmeda |
| K042316 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | Jan 06, 2005 | Substantially Equivalent | Vanguard Medical Concepts, Inc. |
| K033973 | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR | Dec 13, 2004 | Substantially Equivalent | Nellcor Puritan Bennett, Inc. |
| K041127 | MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS | Sep 23, 2004 | Substantially Equivalent | Sterilmed, Inc. |
| K041867 | HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N | Sep 10, 2004 | Substantially Equivalent | Hygia Health Services, Inc. |
| K012715 | HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II | Aug 01, 2003 | Substantially Equivalent | Hygia Health Services, Inc. |
| K012677 | REPROCESSED PULSE OXIMETER SENSORS | Mar 28, 2003 | Substantially Equivalent | Sterilmed, Inc. |
| K012344 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | Oct 04, 2002 | Substantially Equivalent | Vanguard Medical Concepts, Inc. |
| K012622 | CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 | Jul 03, 2002 | Substantially Equivalent | Clearmedical, Inc. |
| K012609 | CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 | Jul 03, 2002 | Substantially Equivalent | Clearmedical, Inc. |
| K012600 | CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L | Jul 03, 2002 | Substantially Equivalent | Clearmedical, Inc. |
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.