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

LFB — Predicate Candidate Screening

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

42 daysmedian FDA review time

96 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K131745	BLOM-SINGER SEPTAL PERFORATION PROSTHESIS	Helix Medical, LLC	2013-09-17	96	0
K013696	SILMED NASAL SEPTAL BUTTON	Silmed, Inc.	2001-11-28	21	0
K982667	MICROMEDICS NASAL SEPTAL BUTTON	Micromedics, Inc.	1998-11-24	116	1
K972060	NASAL SEPTAL BUTTON	Boston Medical Products, Inc.	1997-07-03	31	0
K920994	HOOD NASAL SEPTAL BUTTON	Hood Laboratories	1992-05-15	74	0
K901366	INVOTEC SEPTAL BUTTON	Invotec International, Inc.	1990-06-14	83	0
K871072	OMEGA NASAL SEPTAL BUTTON	Omega Silicone, Inc.	1987-06-08	82	0
K871200	CUI NASAL SEPTUM BUTTON	Cox-Uphuff Intl.	1987-04-15	21	0
K862497	MICROTEK SEPTAL BUTTON	Microtek Medical, Inc.	1986-07-14	13	0
K850492	NASAL SEPTAL BUTTON	Santa Barbara Medco, Inc.	1985-03-07	27	0
K822637	NASAL SEPTAL BUTTONS	Abco Dealers, Inc.	1982-09-28	28	0
K781529	SEPTAL BUTTON	Xomed, Inc.	1978-10-17	42	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