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

FHO — Predicate Candidate Screening

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

56 daysmedian FDA review time

332 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K172120	Veress Needle	Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd	2017-09-14	63
K121370	VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE	Vectec	2013-08-02	452
K010779	MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT	Gibbons Surgical Corp.	2001-04-10	26
K970788	PNEUMO-MATIC INSUFFLATION NEEDLE	Apple Medical Corp.	1997-03-27	23
K960574	ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION	Sherwood Medical Co.	1996-08-05	175
K951894	ACCESS EXPANSION SYSTEM	Micro-Medical Devices, Inc.	1995-06-15	52
K943624	ELMED PNEUMOPERITONEUM NEEDLES	Henke-Sass, Wolf GmbH	1994-08-10	15
K942484	VERRES NEEDLE	Linvatec Corp.	1994-06-24	30
K930474	NEEDLE, PNEUMOPERITONEUM, SPRING LOADED	Ranfac, Corp.	1993-07-23	176
K915725	CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE	Clarus Medical Systems, Inc.	1992-11-16	332
K914426	ENTREE NEEDLE	Core Dynamics, Inc.	1991-11-27	56
K913816	ORIGINEEDLE, MODIFICATION	Origin Medsystems, Inc.	1991-11-08	74
K904849	ORIGINEEDLE(TM)	Origin Medsystems, Inc.	1991-03-29	154
K863330	DISPOSABLE PNEUMOPERITONEUM NEEDLE	United States Surgical, A Division of Tyco Healthc	1986-10-02	44
K844619	ENDONEEDLE	Endotherapeutics	1985-01-09	43

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