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 Stryker Sustainability Solutions.

3
Total
3
Cleared
200d
Avg days
2022
Since

List of Oximeter, Reprocessed devices cleared through 510(k)

3 devices
1–3 of 3
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

How to use this database

This page lists all FDA 510(k) submissions for Oximeter, Reprocessed devices (product code NLF). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Anesthesiology FDA review panel. Browse all Anesthesiology devices →