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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)K112079Substantially equivalent (SESE) · 2012-12-06clearance family

Predicate lineage

K062664

Cited as predicate by: K120035

Cited as predicate by: K141522

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
DateTypeOutcomeFacilityCitations
2015-02-04NAINo action indicatedApex Medical (Kunshan) Corp.2
2014-11-07VAIVoluntary action indicatedWellell Inc0
2014-11-07VAIVoluntary action indicatedWellell Inc0
2012-02-23VAIVoluntary action indicatedWellell Inc2
2012-02-23VAIVoluntary action indicatedWellell Inc2
2011-12-01NAINo action indicatedApex Medical (Kunshan) Corp.0
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