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)K131939Substantially equivalent (SESE) · 2014-03-26clearance family
Predicate lineage
- K131939
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 |
|---|---|---|---|---|
| 2016-10-27 | VAI | Voluntary action indicated | Amico Diagnostic Incorporated | 7 |
| 2016-10-27 | VAI | Voluntary action indicated | Amico Diagnostic Incorporated | 7 |
Similar devices
- 2.8v Specialist ophthalmoscope head & bulb KEELER LIMITED
- 3.5v Specialist ophthalmoscope head & bulb KEELER LIMITED
- 3.6V PROFESSIONAL OPHTH HEAD ONLY KEELER LIMITED
- API 2 LED Wireless Slimline Student Kit KEELER LIMITED
- API 2/2 IN CARTON KEELER LIMITED
- API 2/2 Kit 1 KEELER LIMITED
- API CORDED WITH BLUE FILTER ASSY KEELER LIMITED
- API LED Wireless & Slimline charger KEELER LIMITED
- Avanti OPTOVUE, INC.
- Avanti OPTOVUE, INC.
- Avanti OPTOVUE, INC.
- CANON INC. CANON INC.
Select up to two to place side-by-side with this device.