FDA product code DQA: Oximeter
DQA is the FDA product code for oximeter. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Anesthesiology panel. FDA has cleared 726 510(k) submissions under DQA, 69 in the last five years, from 271 different applicants. The average 510(k) review took 162 days (median 125); 229 days on average over the last three years. FDA has posted 128 recalls for DQA devices, 23 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Oximeter |
| 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 DQA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 220 |
| 2018 | 18 | 262 |
| 2019 | 19 | 164 |
| 2020 | 15 | 146 |
| 2021 | 10 | 199 |
| 2022 | 20 | 288 |
| 2023 | 13 | 353 |
| 2024 | 14 | 305 |
| 2025 | 15 | 213 |
| 2026 | 7 | 169 |
Compare with all 510(k) review times · Search every DQA clearance
Top DQA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Masimo Corporation | 49 | 2023-12-15 |
| Nonin Medical, Inc. | 42 | 2020-06-29 |
| Masimo Corp. | 28 | 2004-07-29 |
| Beijing Choice Electronic Technololgy Co., Ltd. | 21 | 2015-08-28 |
| Nellcor Puritan Bennett, Inc. | 19 | 2007-05-25 |
266 more applicants have DQA clearances. See the full list in Caduvo.
Most recent DQA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252821 | Philips Medizin Systeme Böblingen GmbH | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | 2026-05-29 | 267 |
| K252655 | Shenzhen Imdk Medical Technology Co., Ltd. | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) | 2026-05-11 | 262 |
| K253887 | Philips Medizin Systeme | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) | 2026-05-01 | 148 |
| K260931 | Unimed Medical Supplies, Inc. | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | 2026-04-14 | 25 |
| K252448 | Avita Corporation | AViTA Pulse Oximeter (SP61) | 2026-02-27 | 207 |
Recalls for DQA devices
128 product recalls in 46 recall events; 23 initiated in the last five years and 22 still open. Most recent: 2025-10-24.
| Year | Recalls |
|---|---|
| 2018 | 32 |
| 2019 | 1 |
| 2023 | 9 |
| 2024 | 9 |
| 2025 | 5 |
Frequently asked questions
What is FDA product code DQA?
DQA is the FDA product code for oximeter. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Anesthesiology panel.
What device class is DQA?
Class II, regulation 21 CFR 870.2700. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQA?
Across 726 cleared submissions the average was 162 days from receipt to decision (median 125).
Which companies have the most DQA clearances?
Masimo Corporation (49); Nonin Medical, Inc. (42); Masimo Corp. (28); Beijing Choice Electronic Technololgy Co., Ltd. (21); Nellcor Puritan Bennett, Inc. (19).
Have DQA devices been recalled?
Yes: 128 product recalls across 46 recall events; the most recent began 2025-10-24.
Next steps
- Run an FDA pathway report with predicate devices for product code DQA
- Run a recall and safety report across every DQA manufacturer
- Watch product code DQA 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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