FDA product code · Gastroenterology and urology

Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

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

KDHClass II21 CFR 876.5980510(k) required23 decisions since 19771 recall

23 FDA decisions since 1977. 1 recall names this code; it is not Class I. The most-cited predicate is K951533, named by 1 later device.

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 KDH 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 · KDH

FDA has decided no KDH device since 2007.

Median 510(k) review, days · KDH

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

Recalls per year · KDH

1in 2012

2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · KDH

3in 2022

2007high 10 (2017) · low 0 (2008)2025

MAUDE reports naming product code KDH, 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	2
2008	—	0	0
2009	—	0	0
2010	—	0	1
2011	—	0	0
2012	—	1	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	10
2018	—	0	0
2019	—	0	3
2020	—	0	0
2021	—	0	0
2022	—	0	3
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

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

Planning a device in KDH? 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

Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Which predicates do KDH devices cite most?

Which KDH devices have the deepest lineage?

What has FDA decided in KDH lately?

What has been recalled in KDH lately?

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