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

HDA — Predicate Candidate Screening

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

90 daysmedian FDA review time

697 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K100517	INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX	Instrumed International, Inc.	2010-04-29	65
K092827	DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX	Dimeda Instrumente GmbH	2010-01-08	116
K013747	TEKNO-MEDICAL OBSTETRICAL FORCEPS	Tekno Medical Optik-Chirurgie GmbH & Co.	2002-02-11	90
K951529	V. MUELLER OBSTETRICAL (OB) FORCEPS	Baxter Healthcare Corp	1995-08-04	123
K914552	CMI VACUUM PUMP	Columbia Medical & Surgical, Inc.	1993-09-07	697
K905583	ILC FORCEPS PADS	Inman Liebelt Corp.	1991-04-12	121
K903205	AUTO SUTURE(R) ENDOSCOPIC CLAMP	United States Surgical, A Division of Tyco Healthc	1990-10-11	83
K890385	MIDWIFERY/OBSTETRICAL FORCEPS	Kinetic Medical Products	1989-03-01	37
K851883	SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420	The Huxley Instrument Corp.	1985-05-09	10
K771106	FORCEPS, OB, NON-COMPRESSIVE	Zeppelin Medizinlechnik GmbH	1977-07-01	11

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