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AEROKIT

Model AK10 · AERO HEALTHCARE (US), LLC · DI 09341394014268

LRR — First Aid Kit With Drug

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

01112022-05: 0 reports for this device; peer average 1/device05
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-0501
This device (reports/month)Average device in LRR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — AERO HEALTHCARE (US), LLC

  • VAI 2017-11-20 Aero Healthcare · 4 citations
  • VAI 2017-11-20 Aero Healthcare · 4 citations