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
Predicate lineage
- K143195
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 |
|---|---|---|---|---|
| 2017-04-14 | NAI | No action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 0 |
| 2017-04-14 | VAI | Voluntary action indicated | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 0 |
| 2017-04-14 | VAI | Voluntary action indicated | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 0 |
| 2017-04-14 | NAI | No action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 0 |
| 2015-05-15 | VAI | Voluntary action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 1 |
| 2012-04-12 | VAI | Voluntary action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 5 |
Similar devices
- INFINITY M300 Nellcor WPA2 DRAEGER MEDICAL SYSTEMS, INC.
- """VitalPatch™ Active Patch" Vital Connect, Inc.
- """VitalPatch™ Gentle Patch" Vital Connect, Inc.
- 18-B IR REMOTE RECEIVER PARKS MEDICAL ELECTRONICS, INC.
- 18-B REFURB. IR REMOTE REC. PARKS MEDICAL ELECTRONICS, INC.
- 19-B IR REMOTE RECEIVER PARKS MEDICAL ELECTRONICS, INC.
- 2100-SX & 3100-B REMOTE CHARG- PARKS MEDICAL ELECTRONICS, INC.
- 2100-SX2 FINAL FEATURE ITEM PARKS MEDICAL ELECTRONICS, INC.
- ABYSSAL ABYSSAL, K.K.
- ADVANCED CENTRAL MONITORING STATION ADVANCED INSTRUMENTATIONS, INC.
- ADVANCED PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC.
- ADVANCED PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC.
Select up to two to place side-by-side with this device.