Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K230322Substantially equivalent (SESE) · 2023-06-22clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-02-05 | WL | Warning Letter | Q'apel Medical, Inc. | — |
| 2024-08-08 | OAI | Official action indicated | Qapel Medical Inc. | 7 |
| 2022-03-08 | VAI | Voluntary action indicated | Q'apel Medical, Inc. | 2 |
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