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)K100246Substantially equivalent (SESE) · 2010-11-24clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-03-13 | OAI | Official action indicated | Bio Protech Yantai Inc. | 5 |
| 2020-02-20 | VAI | Voluntary action indicated | Bio Protech Usa, Inc. | 4 |
| 2016-03-25 | NAI | No action indicated | Bio Protech Yantai Inc. | 0 |
| 2016-03-23 | NAI | No action indicated | Bio Protech, Inc. | 0 |
| 2016-03-23 | NAI | No action indicated | Bio Protech, Inc. | 0 |
| 2014-02-26 | VAI | Voluntary action indicated | Bio Protech Usa, Inc. | 0 |
| 2011-08-31 | VAI | Voluntary action indicated | Bio Protech Usa, Inc. | 1 |
| 2010-12-09 | VAI | Voluntary action indicated | Bio Protech, Inc. | 6 |
| 2010-12-09 | VAI | Voluntary action indicated | Bio Protech, Inc. | 6 |
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