FDA product code OLK: Pulse Oximeter For Over-The-Counter Use
OLK is the FDA product code for pulse oximeter for over-the-counter use. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under OLK, 2 in the last five years, from 2 different applicants. The average 510(k) review took 1020 days (median 1020); 1020 days on average over the last three years.
Definition
Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring
Classification
| Field | Value |
|---|---|
| Device name | Pulse Oximeter For Over-The-Counter Use |
| Device class | Class II |
| Regulation | 21 CFR 870.2700 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for OLK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 2 | 1020 |
Compare with all 510(k) review times · Search every OLK clearance
Top OLK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nonin Medical, Inc. | 1 | 2024-11-13 |
| Masimo Corporation | 1 | 2024-01-31 |
Most recent OLK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211498 | Nonin Medical, Inc. | Nonin OTC Pulse Oximeter Model 3250 | 2024-11-13 | 1279 |
| K214115 | Masimo Corporation | MightySat -OTC | 2024-01-31 | 762 |
Recalls for OLK devices
openFDA lists no recalls for product code OLK.
Frequently asked questions
What is FDA product code OLK?
OLK is the FDA product code for pulse oximeter for over-the-counter use. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Anesthesiology panel.
What device class is OLK?
Class II, regulation 21 CFR 870.2700. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLK?
Across 2 cleared submissions the average was 1020 days from receipt to decision (median 1020).
Which companies have the most OLK clearances?
Nonin Medical, Inc. (1); Masimo Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OLK
- Run a recall and safety report across every OLK manufacturer
- Watch product code OLK 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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