FDA product code · Gastroenterology and urology

Ostomy Care Kit

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

PQEClass I21 CFR 876.59000 decisions1 recall

0 FDA decisions. 1 recall names this code; it is not Class I.

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if…

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 PQE 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 · PQE

FDA has decided no PQE device since 2007.

Median 510(k) review, days · PQE

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

Recalls per year · PQE

1in 2017

2007high 1 (2017) · low 0 (2007)2026

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

Adverse event reports per year · PQE

1in 2024

2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code PQE, 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	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	1	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	1
2025	—	0	0
2026	—	0	—

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

Planning a device in PQE? 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 876.5900.

EZQ Pouch, Colostomy EXG Bag, Urine Collecting, Ureterostomy EXB Collector, Ostomy EZS Appliance, Colostomy, Disposable EXA Selector, Size, Ostomy GDS Bag, Stomal EZR Cement, Stomal Appliance, Ostomy EXH Bag, Urinary, Ileostomy EXE Protector, Ostomy FON Bag, Drainage, With Adhesive, Ostomy

Ostomy Care Kit

What has been recalled in PQE lately?

Related product codes