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

HDF — Predicate Candidate Screening

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

27 daysmedian FDA review time

147 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K926429	VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT	Thomasville Medical Assoc.	1994-02-28	432
K902019	MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS	Gynescope Corp.	1990-06-07	35
K891041	MIYA SPECULUM	Zinnanti Surgical Instruments, Inc.	1989-03-22	22
K891044	LASER SPECULA	Zinnanti Surgical Instruments, Inc.	1989-03-17	17
K890375	VAGINAL SPECULUM	Kinetic Medical Products	1989-02-13	21
K862478	HAYES VAGINAL SHIELD	Franklin Medical USA, Inc.	1986-11-24	147
K853640	WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL	Downs Surgical , Ltd.	1985-10-29	70
K851799	61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA	Artiberia	1985-05-22	27
K843388	WELLINGTON HOSPITAL PATTERN SELF-RETAIN	Downs Surgical , Ltd.	1984-10-01	33
K821291	PEDERSON VAGINAL SPECULA	Conphar, Inc.	1982-05-24	20
K821297	GRAVES SPECULA	Conphar, Inc.	1982-05-24	20

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