FDA product code NLF: Oximeter, Reprocessed
NLF is the FDA product code for oximeter, reprocessed. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Anesthesiology panel. FDA has cleared 27 510(k) submissions under NLF, 3 in the last five years, from 13 different applicants. The average 510(k) review took 221 days (median 154); 124 days on average over the last three years. FDA has posted 3 recalls for NLF devices.
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).
Classification
| Field | Value |
|---|---|
| Device name | Oximeter, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.2700 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NLF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 77 |
| 2020 | 1 | 30 |
| 2022 | 2 | 238 |
| 2024 | 1 | 124 |
Compare with all 510(k) review times · Search every NLF clearance
Top NLF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Renu Medical, Inc. | 4 | 2011-11-16 |
| Sterilmed, Inc. | 4 | 2011-02-18 |
| Stryker Sustainability Solutions | 3 | 2024-10-22 |
| Hygia Health Services, Inc. | 3 | 2008-05-28 |
| Clearmedical, Inc. | 3 | 2002-07-03 |
8 more applicants have NLF clearances. See the full list in Caduvo.
Most recent NLF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241758 | Stryker Sustainability Solutions | 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) | 2024-10-22 | 124 |
| K222019 | Stryker Sustainability Solutions | 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) | 2022-12-04 | 149 |
| K211138 | Stryker Sustainability Solutions | 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) | 2022-03-08 | 326 |
| K201699 | Surgical Instrument and Savings Inc (Dba Medline Renewal) | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor | 2020-07-22 | 30 |
| K191018 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | 2019-07-03 | 77 |
Recalls for NLF devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-03-11.
Frequently asked questions
What is FDA product code NLF?
NLF is the FDA product code for oximeter, reprocessed. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Anesthesiology panel.
What device class is NLF?
Class II, regulation 21 CFR 870.2700. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLF?
Across 27 cleared submissions the average was 221 days from receipt to decision (median 154).
Which companies have the most NLF clearances?
Renu Medical, Inc. (4); Sterilmed, Inc. (4); Stryker Sustainability Solutions (3); Hygia Health Services, Inc. (3); Clearmedical, Inc. (3).
Have NLF devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2008-03-11.
Next steps
- Run an FDA pathway report with predicate devices for product code NLF
- Run a recall and safety report across every NLF manufacturer
- Watch product code NLF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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