Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

BYY — Predicate Candidate Screening

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

51 daysmedian FDA review time

84 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K960616	VITAFLOW SUCTION/ASPIRATION TUBING SET	Vital Concepts, Inc.	1996-05-06	83	6
K960218	CONNECTING TUBING	Custom Pack Reliability	1996-03-28	72	0
K955149	MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL	Bio-Medical Devices, Inc.	1996-01-24	72	0
K955151	MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR	Bio-Medical Devices, Inc.	1996-01-24	72	0
K955150	MAXI-FLOW	Bio-Medical Devices, Inc.	1996-01-23	71	0
K922989	WILTEK IRRIGAITON/ASPIRATION TUBE SET	Wiltek Medical, Inc.	1994-02-15	603	0
K911586	GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)	Megadyne Medical Products, Inc.	1991-07-02	84	0
K901761	STERILE SUCTION TUBING SET	Acacia Laboratories, Inc.	1990-05-07	19	0
K873463	VAN DELLEN ASPIRATING TUBING	Van Dellen, Ltd.	1987-11-23	87	0
K853296	EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN	Parexel Intl. Corp.	1985-08-15	9	0
K843470	PHARMA-PLAST CONNECTING TUBE TYPE SUCT-	Zimmar Consulting , Ltd.	1984-11-16	71	0
K832865	FLEX BUBBLE TUBING	Sheridan Catheter Corp.	1983-09-29	37	0
K832398	DYNACOR CONNECTING TUBING	Medline Industries, Inc.	1983-08-24	35	0
K831920	PLASTIC TUBING CONNECTORS	Polymer Technology Corp.	1983-07-19	35	0
K821703	MGN CONDUCTIVE CONNECTING TUBE, STERILE	Mgn Medical Manufacturing, Inc.	1982-06-22	20	0
K820371	PLASTIC CONNECTORS	American Pharmaseal Div. Ahsc	1982-04-01	51	0
K820412	AM. PH. STERILE PLASTIC CONNECTING TUBES	American Pharmaseal Div. Ahsc	1982-03-31	47	0
K813228	CONNECTING TUBE	Northern Medical Industries	1981-11-27	17	0
K811541	MGN CONNECTING TUBE	Mgn Medical Manufacturing, Inc.	1981-06-18	17	0
K800235	ABCO CONNECTING TUBES PRECUT LENGTHS	Abco Dealers, Inc.	1980-02-26	21	0
K790420	SUCTION CONNECTING TUBING	Snyder Laboratories, Inc.	1979-04-23	54	0
K790419	YANKAUER & POODLE SUCTION INSTRUMENTS	Snyder Laboratories, Inc.	1979-04-23	54	0
K780724	BUBBLE SUCTION TUBING	Davol, Inc.	1978-06-02	30	0
K761079	FLEXIBLE TIP ASPIRATING TUBES	Pilling Co.	1976-12-09	20	0

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