Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

EXD — Predicate Candidate Screening

12 FDA 510(k) clearances under this product code; the 50 most recent screened below.

35 daysmedian FDA review time

149 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K121833	OSTOMY IRRIGATION SET	Coloplast A/S	2012-07-16	24
K914692	URINARY DIVERSION EVACUATING CATHETER	Cook Urological, Inc.	1992-07-02	258
K904586	PALEX IRRIGATION SET	Palex Intl. SA	1990-12-28	80
K871791	BLOXOM IRRIGATOR	I.B. Bloxom C/O Hogan & Hartson	1987-05-20	13
K840268	IRRIGATION SYSTEM	Coloplast A/S	1984-04-05	73
K832299	VISI-FLOW IRRIGATOR	Convatec, A Division of E.R. Squibb & Sons	1983-08-26	44
K823274	UNI-TIP COLOSTOMY IRRIGATION CONE	Howmedica Corp.	1982-12-07	34
K811160	SUR-FIT IRRIGATION SLEEVE	E. R. Squibb & Sons, Inc.	1981-06-02	35
K790749	COLOSTOMY ENEMA DEVICE	Vabar Corp.	1979-05-16	29
K790750	COLOSTOMY DEVICE W/ PRESSURE LID	Vabar Corp.	1979-05-14	27
K760810	TUBE, GASTRO-ENTEROSTOMY	Sherwood Medical Industries	1977-02-28	149
K770251	SUPER X ADJUSTRETTE	Qualitone	1977-02-28	19

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda