Ashvins · recalls, adverse events, clearances

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

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2025-09-09	Z-2673-2025	Class II	Open, Classified	Potential that the measured value may be smaller than the actual area.Distribution: US Nationwide distribution.	474 units	clearance family

Regulatory clearances

510(k)K200132Substantially equivalent (SESE) · 2020-02-18clearance family

Predicate lineage

K200132
- K122938
  - K090439
  - K093313
- K142750
  - K053183
  - K132532
    - K101666
      - K092519

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

None in the loaded window.

Similar devices