Product code DQA: 510(k) clearances and predicates
Product code DQA covers Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T). FDA lists 726 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
726 clearances on file under product code DQA. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 20 |
| 2023 | 13 |
| 2024 | 14 |
| 2025 | 15 |
| 2026 so far | 7 |
Recent clearances
Newest DQA clearances in the FDA index, with applicant and decision date:
- K252821, Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T), applicant Philips Medizin Systeme Böblingen GmbH, decided 2026-05-29. FDA record
- K252655, Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT), applicant Shenzhen Imdk Medical Technology Co., Ltd., decided 2026-05-11. FDA record
- K253887, Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401), applicant Philips Medizin Systeme, decided 2026-05-01. FDA record
- K260931, Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R), applicant Unimed Medical Supplies, Inc., decided 2026-04-14. FDA record
- K252448, AViTA Pulse Oximeter (SP61), applicant Avita Corporation, decided 2026-02-27. FDA record
- K252805, YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310), applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., decided 2026-02-17. FDA record
- K253109, Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O), applicant Shenzhen Best Electronics Co., Ltd., decided 2026-01-07. FDA record
- K251751, Spo2 Sensor CSS032D, applicant Shenzhen Ykd Technology Co., Ltd., decided 2025-12-19. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT), Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401). Watch new DQA clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DQA?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DQA clearances include Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T).
How many 510(k) clearances use product code DQA?
726 at the time this page was generated, from openFDA records.
How do I find a predicate device under DQA?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DQA clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.