FDA product code · Gastroenterology and urology

Gastrostomy Jejunostomy Feeding Tube Kit

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

PRYClass II21 CFR 876.59800 decisions0 recalls

0 FDA decisions. No recall names this code.

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 PRY 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 · PRY

FDA has decided no PRY device since 2007.

Median 510(k) review, days · PRY

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

Recalls per year · PRY

No recall names PRY since 2007.

Adverse event reports per year · PRY

1in 2018

2007high 1 (2018) · low 0 (2007)2025

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

View these four charts as a table

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

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

Planning a device in PRY? 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 876.5980.

PSG Percutaneous Endoscopic Gastrostomy Kit PIF Gastrointestinal Tubes With Enteral Specific…PSI Perineal Irrigation Kit EYN Tray, Irrigation, Sterile PSE Needle Catheter Jejunostomy Kit FPD Tube, Feeding FHT Set, Gavage, Infant, Sterile LCG Intestinal Splinting Tubes NGU Balloon, Liver Tamponade PRT Gastric Irrigation And Aspiration Kit PSH Percutaneous Replacement Gastrostomy Tube Kit PLI Gastrointestional Tube Holder