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

FCE — Predicate Candidate Screening

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

70 daysmedian FDA review time

133 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days
K974042	AMSURE CLEANSING ENEMA SET	Amsino Intl., Inc.	1997-12-19	56
K931896	PRO-FLO SYSTEM	Lafayette Pharmacal, Inc.	1993-08-26	133
K922398	4 SURE TM ENEMA BAG SET	Boston Pacific Medical, Inc.	1993-06-17	392
K913620	ENEMA KIT	York County Blind Center	1991-11-01	80
K904534	ENEMA BULB	R.A.C., Inc.	1990-12-21	78
K901179	ENEMA BUCKET SET	Orion Life Systems, Inc.	1990-06-28	107
K901182	ENEMA BAG SET	Orion Life Systems, Inc.	1990-06-28	107
K900847	ENEMA KIT 'Y' DESIGN	Custom Medical Products, Ltd.	1990-04-13	50
K900848	ENEMA KIT 'STRAIGHT' DESIGN	Custom Medical Products, Ltd.	1990-04-13	50
K881218	GENT-L-KARE CLEANSING ENEMA SET	Geneva Laboratories, Inc.	1988-07-28	128
K880337	MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700	Plasco, Inc.	1988-04-14	79
K872992	SPS SUSPENSION ENEMA KIT	Carolina Medical Products Co.	1987-09-17	48
K870019	THE LAHR BALLOON	Plasco, Inc.	1987-04-01	89
K870796	MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY	Plasco, Inc.	1987-04-01	33
K843792	VAN JON SUPER CLYSTER(KIT, ENEMA	Van Jon Co.	1985-04-22	207
K842130	G.I. CLEANSING KIT	Mmi, Inc.	1984-08-08	70
K832960	SHUFFIELD TECH ENEMA TIP	Shuffield Tech Co.	1984-01-03	126
K833860	TUCK-TITE COLON FLUID RETAINER	Clayton Medical Products, Inc.	1983-12-27	50
K800961	ENEMA CONTAINER DISP. FOR EMEMA ADMIN.	The Healthcare Group Laboratories, Inc.	1980-05-14	21
K800959	LARGE VOLUME ENEMA CONTAINER DISPOSABLE	The Healthcare Group Laboratories, Inc.	1980-05-14	21
K800960	1500 ML DISPOSABLE ENEMA CONTAINER(1110)	The Healthcare Group Laboratories, Inc.	1980-05-14	21
K791863	MAC LEE ENEMAD	Mac Lee Medical Products	1979-10-02	8
K790535	CLAYTON COLON CLEANSING KIT	Clayton Medical Products, Inc.	1979-06-07	78
K790005	ADMINISTRATION SET, ENEMA	Kelsar Corp.	1979-01-17	15
K780877	ENEMA BAG	Abco Dealers, Inc.	1978-08-14	76
K780613	ENEMA, PHOSPHATE	Abco Dealers, Inc.	1978-06-02	53
K771792	ENEMA SET	Chase Mfg. Co.	1977-10-20	28
K770300	COLON IRRIGATION DEV.,COLON-A-SUN COLONI	Sun Product Dist., Inc.	1977-03-30	43
K760777	COLON-X	Carlton Hygienics, Inc.	1977-01-13	101
K761167	ENEMA KIT	American Hospital Supply Corp.	1976-12-09	8

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