Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

NHB — Predicate Candidate Screening

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

137 daysmedian FDA review time

314 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260620	SeptAlign (SPLN001)	Spirair, Inc.	2026-07-30	155	0
K251790	SeptAlign	Spirair, Inc.	2026-01-16	219	0
K233569	SeptAlign	Spirair, Inc.	2024-03-22	137	0
K223167	Spirair Nasal Septal Strap	Spirair, Inc.	2023-08-17	314	0
K210411	PosiSep EAR Fragmentable Ear Dressing	Hemostasis, LLC	2022-05-05	448	0
K192661	LATERA Absorbable Nasal Implant System	Entellus Medical, Inc. (Aka Stryker Ent)	2019-11-10	46	0
K183015	PuraSinus	3-D Matrix, Inc.	2019-04-12	163	0
K161191	Latera Absorbable Nasal Implant	Spirox, Inc.	2016-06-23	57	0
K152958	INEX Absorbable Nasal Implant	Spirox, Inc.	2015-12-04	58	0
K132920	SPIROX INEX DEVICE	Spirox, Inc.	2014-06-10	266	0
K122434	MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS ST	Medtronic Xomed	2012-10-31	82	0
K092590	PDS PLATES	ETHICON, Inc.	2010-02-17	177	0
K070715	NASOPORE EAR	Polyganics B.V.,	2007-05-07	54	13
K070886	MEROGEL INJECTABLE BIORESORBABLE STENT	Medtronic, Inc.	2007-04-26	27	0
K012769	MACROPORE ENT RECONSTRUCTION FILM	Macropore Biosurgery, Inc.	2001-10-25	69	0
K012409	LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS	Walter Lorenz Surgical, Inc.	2001-10-18	80	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