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Airgle

Model AG900 · Airgle Corporation · DI 00860013509927

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

UDILibrary device dossier · generated 2026-09-12 · 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.

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2021-05	0	2

This device (reports/month)Average device in FRA (reports/device/month)

Regulatory clearances

K232645 SESE 2024-02-16 (k number procode)

Predicate lineage

K232645 — cites (transitively): K202339 (d1), K212824 (d1), K200500 (d2), K062716 (d2), K052732 (d3), K161468 (d3)

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

Manufacturer compliance record — Airgle Corporation

Nothing in the loaded window.