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., Stryker Sustainability Solutions and Vanguard Medical Concepts, Inc..

27
Total
27
Cleared
221d
Avg days
2002
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 124d recently vs 225d historically

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 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 Jul 29, 2008
REPROCESSED MASIMO PULSE OXIMETER SENSORS
K081238
Ascent Healthcare Solutions
Anesthesiology · 89d
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 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 remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - NLF Product Code

Recent submissions under NLF have taken an average of 124 days to reach a decision - down from 225 days historically, suggesting improved FDA processing for this classification.

NLF devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →