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

HRQ — Predicate Candidate Screening

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

33 daysmedian FDA review time

67 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K920298	DISPOSABLE HEMOSTATS	Falcon Instruments, Inc.	1992-08-11	202
K895683	BERNARD VESSEL APPROXIMATOR	Applied Medical Technologies	1989-10-24	33
K890245	SURGICAL HEMOSTATS	Kinetic Medical Products	1989-01-27	9
K884196	SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)	Disposable Sterile Surgical Instruments, Inc.	1988-11-08	35
K881937	SURGICAL INSTRUMENTS	Far East Intl. Trading Corp.	1988-06-15	37
K861807	MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)	Medcomp Technologies, Inc.	1986-05-23	14
K844152	HEMSTATS	I M, Inc.	1984-11-07	14
K843593	SURGIPRESS SURGICAL LOOP	Syntex Corp.	1984-10-24	42
K841514	SCANLAN VASCU-STATT II APPROXIMATOR	Scanlan Intl., Inc.	1984-06-05	54
K834175	OP-CON SURG. INSTRUMENTS #11	Imm Enterprises , Ltd.	1984-01-27	67
K831797	HEMOSTATS	I M, Inc.	1983-07-19	46
K823694	VASCU-STATT APPROXIMATOR	Scanlan Intl., Inc.	1983-01-07	30
K822263	VARIOUS TYPES OF TONSILS HEMOSTATS	Kelleher Corp.	1982-08-16	18
K821887	SCANLAN SUTURE-STATT	Scanlan Intl., Inc.	1982-07-28	33
K821617	DISPOSABLE HEMOSTATS	Medcare Products	1982-06-21	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