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Aerobiotix

Model AeroCure-MD · AEROBIOTIX USA LLC · DI 00852348007773

FRA — Purifier, Air, Ultraviolet, Medical · Class II · 21 CFR 880.6500

UDILibrary device dossier · generated 2026-09-13 · 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.

11222021-05: 0 reports for this device; peer average 2/device05
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0502
This device (reports/month)Average device in FRA (reports/device/month)

Regulatory clearances

  • K203189 SESE 2021-01-21 (k number procode)

Predicate lineage

K203189 — cites (transitively): K972064 (d1), K974682 (d1) — cited as predicate by K220298

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — AEROBIOTIX USA LLC

  • VAI 2024-04-11 AeroBiotix USA · 3 citations
  • VAI 2024-04-11 AeroBiotix USA · 3 citations
  • VAI 2022-03-09 AeroBiotix USA · 2 citations
  • VAI 2022-03-09 AeroBiotix USA · 2 citations
  • VAI 2018-11-14 AeroBiotix USA · 4 citations
  • VAI 2018-11-14 AeroBiotix USA · 4 citations