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

LYT — Predicate Candidate Screening

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

65 daysmedian FDA review time

130 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K040363	CERAMIC TIPPED SKULL PIN	The Jerome Group, Inc.	2004-04-12	59	3
K983685	BONE BAND	Chapel and Assoc.	1998-12-04	45	0
K980594	OSTEONICS FX-CABLELOK GRIP COMPONENTS	Osteonics Corp.	1998-05-05	77	0
K914812	K-CAP-E, STERILE	Westcon Orthopedics, Inc.	1992-01-09	76	0
K912762	K-CAP-I, STERILE	Westcon Orthopedics, Inc.	1991-07-18	24	0
K902676	MICROGUARD, ORTHOPEDIC PIN PROTECTORS	Micro-Aire Surgical Instruments, Inc.	1990-09-14	87	0
K902053	K-CAP-I ORTHOPEDIC FIXATION WIRE CAP	Westcon Orthopedics, Inc.	1990-09-14	130	0
K883576	HORIZON ORTHOPEDIC PIN PROTECTOR	Horizon Medical, Inc.	1988-09-30	39	0
K831072	JURGAN PIN BALL	Jurgan Development & Mfg., Ltd.	1983-06-08	65	0

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