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

HXD — Predicate Candidate Screening

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

14 daysmedian FDA review time

28 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K890368	KIDNEY CLAMP	Kinetic Medical Products	1989-02-03	11
K890371	INTESTINAL CRUSHING CLAMP	Kinetic Medical Products	1989-02-03	11
K890372	INTESTINAL CLAMP	Kinetic Medical Products	1989-02-03	11
K890381	PARAMETRIUM CLAMP	Kinetic Medical Products	1989-02-03	11
K874959	VASCULAR CLAMP	Solway, Inc.	1987-12-30	28
K872386	C CLAMP	Med-Tool, Inc.	1987-07-02	13
K863653	SUCTION-OFF	B&B Medical Technologies, Inc.	1986-10-07	19
K853538	CANNULA CLAMP	Cp Medical	1985-09-12	20
K851654	OMNIMED CLAMP	Omni Intl., Inc.	1985-05-31	39
K801819	SURGICAL INSTRUMENTS	Robert I. Chien & Assoc., Inc.	1980-08-20	20
K801028	RICA OR SMIC SURGICAL INSTRUMENTS	Robert I. Chien & Assoc., Inc.	1980-05-20	19
K791289	GIZMO TOWEL CLAMP	Hemoy, Inc.	1979-07-24	14
K782090	CLAMP, DISPOSABLE	Concord Laboratories, Inc.	1978-12-20	6
K770118	CARPENTER BONE CLAMP	Stryker Corp.	1977-01-26	5

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