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.

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

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 Review Time

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 →