FDA product code · Gastroenterology and urology

Bag, Urine Collection, Leg, For External Use, Non-Sterile

Name: FDA decisions, review times, recalls and adverse event reports for product code NNW
Creator: 510(k) Report

NNWClass I21 CFR 876.5250510(k) exempt0 decisions1 recall

FDA lists NNW as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 876.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 1 recall names this code; it is not Class I.

Urine collector and accessories; see product code FAQ.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, gastroenterology and urology panel

Twenty years of NNW at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NNW

FDA has decided no NNW device since 2007.

Median 510(k) review, days · NNW

Too few NNW 510(k)s in any year since 2007 to give a median.

Recalls per year · NNW

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NNW

1in 2025

2007high 7 (2010) · low 0 (2007)2025

MAUDE reports naming product code NNW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	7
2011	—	0	4
2012	—	0	1
2013	—	0	1
2014	—	1	1
2015	—	0	2
2016	—	0	4
2017	—	0	4
2018	—	0	4
2019	—	0	0
2020	—	0	1
2021	—	0	1
2022	—	0	1
2023	—	0	2
2024	—	0	1
2025	—	0	1
2026	—	0	—

FIG. 1 — NNW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NNW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 876.5250.

EXJ Device, Incontinence, Urosheath Type, Sterile EYZ System, Urine Drainage, Closed, For…FFH Collector, Urine, Pediatric, For Indwelling…KNX Collector, Urine, (And Accessories) For…EYT Sheath, Corrugated Rubber, For Nonindwelling…FAQ Bag, Urine Collection, Leg, For External Use…FOC Bag, Urine Collection, Newborn NNY Sheath, Corrugated Rubber, For Non-Indwelling…EXI Device, Paste-On For Incontinence, Sterile NOA Device, Paste-On For Incontinence, Non-Sterile NNX Device, Incontinence, Urosheath Type…NNZ System, Urine Drainage, Closed, For…

Bag, Urine Collection, Leg, For External Use, Non-Sterile

What has been recalled in NNW lately?

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