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Model RTL19K005-2 · Drive Devilbiss Healthcare · DI 00822383010809

FNP — Urinal · Class I · 21 CFR 880.6730

UDILibrary device dossier · generated 2026-09-07 · 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)
2019-08	0	2
2023-08	0	2
2024-02	0	6
2025-10	0	1

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

Regulatory clearances

None linked in the loaded window.

Manufacturer compliance record — Drive Devilbiss Healthcare

Warning Letter 2021-11-23 DeVilbiss Healthcare LLC
Warning Letter 2012-10-10 Drive DeVilbiss Healthcare

NAI 2024-05-30 DeVilbiss Healthcare LLC · 0 citations
OAI 2022-08-17 DeVilbiss Healthcare LLC · 4 citations
OAI 2021-08-25 DeVilbiss Healthcare LLC · 9 citations
VAI 2016-02-24 Drive DeVilbiss Healthcare · 0 citations
NAI 2016-01-28 DeVilbiss Healthcare LLC · 0 citations
VAI 2014-07-18 Drive DeVilbiss Healthcare · 3 citations
OAI 2012-08-31 Drive DeVilbiss Healthcare · 8 citations
NAI 2012-02-22 DeVilbiss Healthcare LLC · 0 citations
NAI 2010-03-31 DeVilbiss Healthcare LLC · 0 citations