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

HFW — Predicate Candidate Screening

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

81 daysmedian FDA review time

286 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days
K041332	JOEY CLAMP OPENING TOOL	Maternus, Inc.	2004-06-25	37
K033846	KAEN YIH UMBILICAL CORD CLAMP	Kaen Yih Enterprise Co., Ltd.	2004-03-11	91
K020718	SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERI	Precision Dynamics Corp.	2002-06-03	90
K021055	BUSSE UMBILICAL CORD CLAMP CUTTER	Busse Hospital Disposables, Inc.	2002-04-29	28
K012917	DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B	Dynarex Corp.	2001-11-28	90
K011621	KOALA CLAMP, KOALA CLAMP AND CUTTER	Maternus, Inc.	2001-08-10	77
K010695	KOALA CLAMP	Maternus, Inc.	2001-05-03	56
K010835	POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRI	Busse Hospital Disposables, Inc.	2001-04-30	41
K000227	UMBICUT	Pollak (Intl.), Ltd.	2000-04-27	94
K994367	UMBILICAL CORD CLAMP	Medical Sales Co.	2000-03-17	81
K994263	SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540	Precision Dynamics Corp.	2000-01-24	38
K990737	'ECURLINE UMBILICAL CORD CLAMP #3500	Precision Dynamics Corp.	1999-04-06	32
K983204	HARWILL MEDICAL U-KLIP UMBILICAL CLAMP	Harwill Medical (Pty) , Ltd.	1999-02-26	165
K974227	HOSPITAL'S CLAMP	Gps	1997-12-12	30
K963223	EZ-CIRC	Phyllis Adams, Rn, Npc, Msn	1997-04-23	250
K963889	QFC UMBILICAL CLAMP	Qfc Industries	1997-04-18	204
K963428	UMBILICAL CLAMP AND CUTTER	R.O.S.T. Medical Development, Inc.	1997-04-01	214
K945841	BIRTH THEFT INFANT IDENTIFICATION AND PROTECTION UMBILICAL C	W G M Corp.	1995-05-30	181
K951140	KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR	Balagan Medical, Inc.	1995-05-25	73
K933763	SAVE-T-BREATH AMBILICAL CORD CLAMP	Save-T-Breath Distributors C.C.	1994-08-29	391
K934525	AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER	United States Surgical, A Division of Tyco Healthc	1994-02-14	150
K923439	LUNEAU UMBILICAL CORD CLAMP	Laboratoires Luneau	1993-05-21	312
K912419	CORDGUARD BLOOD COLLECTION DEVICE	O.B. Tech., Inc.	1992-10-05	493
K915569	UMBILICAL CLAMP	Gam Industries, Inc.	1992-09-23	286
K912054	LABOR DELIVERY TRAY	Medical Device Inspection Co., Inc.	1992-01-21	257
K912869	WOMEN AND INFANT'S DELIVERY PACK	Welcon, Inc.	1991-12-04	159
K901954	AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC	Hollister, Inc.	1990-07-26	86
K901557	UMBILICAL CORD CLAMP AND CUTTER	Microtek-Heritage, Inc.	1990-05-15	42
K894646	#556 DISPOSABLE UMBILICAL CORD CLAMP (2)	Alpha Unlimited, Inc.	1989-09-05	43
K890382	COMPRESSION FORCEPS	Kinetic Medical Products	1989-02-27	35
K880753	UMBILICAL CORD CLAMP	I M, Inc.	1988-04-27	62
K871075	SCMT UMBILICAL CLAMP	Salt Creek Medical Technologies	1987-03-23	5
K870446	DOLPHIN UMBILICAL CORD CLAMP	Andermac, Inc.	1987-02-17	14
K863645	SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000	United Medical Systems, Inc.	1986-09-25	7
K860445	CLAMP-N-CUT	Mmi, Inc.	1986-04-04	59
K781548	UMBILICAL CORD CLAMP	Hollister, Inc.	1978-10-17	35

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