FDA product code · Gastroenterology and urology

Foley Catheter Kit (Excludes Hiv Testing)

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

PPBClass II21 CFR 876.51300 decisions4 recalls

0 FDA decisions. 4 recalls name this code, 0 of them 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 PPB 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 · PPB

FDA has decided no PPB device since 2007.

Median 510(k) review, days · PPB

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

Recalls per year · PPB

2in 2024

2007high 2 (2024) · low 0 (2007)2026

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

Adverse event reports per year · PPB

13in 2025

2007high 50 (2024) · low 0 (2007)2025

MAUDE reports naming product code PPB, 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	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	17
2024	—	2	50
2025	—	0	13
2026	—	2	—

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

Planning a device in PPB? 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 876.5130.

PPA Bladder Irrigation Kit KOD Catheter, Urological FGI Catheter, Urethrographic, Male GBM Catheter, Urethral EYB Catheter, Ureteral, Gastro-Urology FCM Tray, Catheterization, Sterile Urethral, With…EYI Adaptor, Ureteral Catheter GBL Catheter, Ureteral, General & Plastic Surgery LJH System, Irrigation, Urological MJC Catheter, Urological (Antimicrobial) And…OHR Catheter Care Tray EZC Catheter, Coude

Foley Catheter Kit (Excludes Hiv Testing)

What has been recalled in PPB lately?

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