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 Masimo Corporation.
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
Cleared
Oct 22, 2024
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000)
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)
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)
Stryker Sustainability Solutions
Anesthesiology
326d
Cleared
Jul 22, 2020
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
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
Surgical Instrument Service and Savings, Inc.
Anesthesiology
77d
Cleared
Jul 28, 2011
M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
Masimo Corporation
Anesthesiology
134d
Cleared
Feb 18, 2011
REPROCESSED PULSE OXIMETER SENSORS
Sterilmed, Inc.
Anesthesiology
164d
Cleared
Nov 03, 2009
REPROCESSED PULSE OXIMETER SENSORS
Sterilmed, Inc.
Anesthesiology
90d
Cleared
Jul 30, 2009
LNCS OXIMETRY SENSORS
Masimo Corporation
Anesthesiology
227d
Cleared
Jun 29, 2005
DATEX-OHMEDA OXY-AFR SENSOR
Datex-Ohmeda
Anesthesiology
253d
Cleared
Dec 13, 2004
OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
Nellcor Puritan Bennett, Inc.
Anesthesiology
357d
Cleared
Sep 23, 2004
MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
Sterilmed, Inc.
Anesthesiology
146d
Cleared
Mar 28, 2003
REPROCESSED PULSE OXIMETER SENSORS
Sterilmed, Inc.
Anesthesiology
591d
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 →