Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Medical Guardian

Model F170A · Aerus LLC · DI 00860006514808

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

  • K201220 SESE 2020-06-17 (k number procode)

Predicate lineage

K201220 — cited as predicate by K221540

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

Manufacturer compliance record — Aerus LLC

  • VAI 2010-06-14 Aerus, Llc · 8 citations