NLF · Class II · 21 CFR 870.2700

FDA Product Code NLF: Oximeter, Reprocessed

FDA product code NLF covers reprocessed pulse oximeters cleared for oxygen saturation monitoring after validated reprocessing.

Reusable pulse oximeter probes and sensors are reprocessed to restore sterility and functionality for reuse between patients. Reprocessed NLF devices must meet the same sensor calibration and accuracy requirements as original devices.

NLF devices are Class II medical devices, regulated under 21 CFR 870.2700 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include Sterilmed, Inc., Renu Medical, Inc. and Stryker Sustainability Solutions.

27
Total
27
Cleared
221d
Avg days
2002
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Oximeter, Reprocessed Devices (Product Code NLF)

27 devices
1–24 of 27
Cleared Oct 22, 2024
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000)
K241758
Stryker Sustainability Solutions
Anesthesiology · 124d
Cleared Dec 04, 2022
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)
K222019
Stryker Sustainability Solutions
Anesthesiology · 149d
Cleared Mar 08, 2022
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)
K211138
Stryker Sustainability Solutions
Anesthesiology · 326d
Cleared Jul 22, 2020
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
K201699
Surgical Instrument and Savings Inc (Dba Medline Renewal)
Anesthesiology · 30d
Cleared Jul 03, 2019
Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
K191018
Surgical Instrument Service and Savings, Inc.
Anesthesiology · 77d
Cleared Nov 16, 2011
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
K111773
Renu Medical, Inc.
Anesthesiology · 146d
Cleared Jul 28, 2011
M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
K110723
Masimo Corporation
Anesthesiology · 134d
Cleared Feb 18, 2011
REPROCESSED PULSE OXIMETER SENSORS
K102560
Sterilmed, Inc.
Anesthesiology · 164d
Cleared Oct 07, 2010
MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
K101280
Midwest Reprocessing Center, LLC
Anesthesiology · 154d
Cleared Nov 03, 2009
REPROCESSED PULSE OXIMETER SENSORS
K092368
Sterilmed, Inc.
Anesthesiology · 90d
Cleared Jul 30, 2009
LNCS OXIMETRY SENSORS
K083719
Masimo Corporation
Anesthesiology · 227d
Cleared Feb 06, 2009
RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO
K081927
Renu Medical, Inc.
Anesthesiology · 214d
Cleared Jul 29, 2008
REPROCESSED MASIMO PULSE OXIMETER SENSORS
K081238
Ascent Healthcare Solutions
Anesthesiology · 89d
Cleared May 28, 2008
HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
K080424
Hygia Health Services, Inc.
Anesthesiology · 103d
Cleared Nov 29, 2007
RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
K072194
Renu Medical, Inc.
Anesthesiology · 114d
Cleared May 25, 2007
RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20
K063661
Renu Medical, Inc.
Anesthesiology · 168d
Cleared Jun 29, 2005
DATEX-OHMEDA OXY-AFR SENSOR
K042891
Datex-Ohmeda
Anesthesiology · 253d
Cleared Jan 06, 2005
VANGUARD REPROCESSED PULSE OXIMETER SENSORS
K042316
Vanguard Medical Concepts, Inc.
Anesthesiology · 133d
Cleared Dec 13, 2004
OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
K033973
Nellcor Puritan Bennett, Inc.
Anesthesiology · 357d
Cleared Sep 23, 2004
MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
K041127
Sterilmed, Inc.
Anesthesiology · 146d
Cleared Sep 10, 2004
HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N
K041867
Hygia Health Services, Inc.
Anesthesiology · 63d
Cleared Aug 01, 2003
HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
K012715
Hygia Health Services, Inc.
Anesthesiology · 717d
Cleared Mar 28, 2003
REPROCESSED PULSE OXIMETER SENSORS
K012677
Sterilmed, Inc.
Anesthesiology · 591d
Cleared Oct 04, 2002
VANGUARD REPROCESSED PULSE OXIMETER SENSORS
K012344
Vanguard Medical Concepts, Inc.
Anesthesiology · 437d

About Product Code NLF - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code NLF since 2002, with 27 receiving FDA clearance (average review time: 221 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.