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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)K093889Substantially equivalent (SESE) · 2010-04-22clearance family

Predicate lineage

Cited as predicate by: K103537

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
2025-07-23VAIVoluntary action indicatedHiossen Inc.1
2025-07-23VAIVoluntary action indicatedHiossen Inc.1
2017-04-24NAINo action indicatedHiossen Inc.0
2017-04-24NAINo action indicatedHiossen Inc.0
2017-04-12VAIVoluntary action indicatedHiossen Inc.2
2017-04-12VAIVoluntary action indicatedHiossen Inc.2
2013-04-18VAIVoluntary action indicatedHiossen Inc.0
2013-04-18VAIVoluntary action indicatedHiossen Inc.0
2012-10-05WLWarning LetterHiossen Inc.—
2012-10-05WLWarning LetterHiossen Inc.—
2012-05-16OAIOfficial action indicatedHiossen Inc.0
2012-05-16OAIOfficial action indicatedHiossen Inc.0
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