NLFClass II

Oximeter, Reprocessed

21 CFR 870.2700 / Cardiovascular

NLF is the FDA product code for Oximeter, Reprocessed, a class II device type, regulated under 21 CFR 870.2700. FDA's definition for this code reads: "same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". As of 2026-09-10, FDA records hold 27 510(k) clearances under this code, the most recent dated 2024-10-22, and 3 recalls.

Classification record

Product code: NLF
Device name: Oximeter, Reprocessed
FDA definition: same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation: 21 CFR 870.2700
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 27
Ingested recalls: 3

Clearances, product code NLF

By decision year

27 clearances under product code NLF with a decision year between 2002 and 2024, 2002 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code NLF by decision year
Year	Clearances
2002	4
2003	2
2004	3
2005	2
2007	2
2008	2
2009	3
2010	1
2011	3
2019	1
2020	1
2022	2
2024	1

Applicants with the most clearances

Product code NLF

Applicants holding the most 510(k) clearances under product code NLF
Applicant	Clearances
Stryker Sustainability Solutions	6
Renu Medical, Inc.	4
Sterilmed Inc	4
Clearmedical, Inc.	3
Hygia Health Services, Inc.	3
Masimo Corporation	2
GE Healthcare	1
Midwest Reprocessing Center, LLC	1
Medtronic, Inc.	1
Medline ReNewal	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order