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

KOH — Predicate Candidate Screening

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

70 daysmedian FDA review time

796 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K000212	KSEA CHARDONNES MORCELLATION KNIFE	KARL STORZ Endoscopy-America, Inc.	2000-04-21	88
K921730	C-SECTION PACK	Medikmark, Inc.	1994-06-15	796
K921732	MINOR LAP SET	Medikmark, Inc.	1994-06-15	796
K891351	NEWPORT LATERAL VAGINAL RETRACTOR	Simpson/Basye, Inc.	1989-05-11	62
K892693	VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT	Zinnanti Surgical Instruments, Inc.	1989-05-11	28
K891035	NEEDLE EXTENSIONS	Zinnanti Surgical Instruments, Inc.	1989-03-22	22
K891049	ZEPPELIN SCISSORS	Zinnanti Surgical Instruments, Inc.	1989-03-17	17
K863610	THE OB-GYN CONCEPTS VAGINAL ASPIRATOR	Ob/Gyn Concepts, Ltd.	1987-01-07	113
K840308	CAT. 4-OBSTETRICS GYNECOLOGY DEV'S	Imm Enterprises , Ltd.	1984-03-05	41
K823792	QUARTZ RETRACTOR/PROBE	American V. Mueller	1983-01-18	34
K812204	UTERINE MANIPULATORS	Reznik Instruments	1981-10-13	70
K800834	SER-TEX	V.S.S.I., Inc.	1980-06-30	77
K790851	VAGI-PRESS #401	C. Intl.	1979-07-30	87
K781767	INSTRUMENT CURNETT MINI-CONER BIOPSY	C.R. Bard, Inc.	1978-12-07	52
K780460	DENTAL AIR BRUSH	M. Joel Gebhart, D.D.S.	1978-06-28	98

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