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

LYA — Predicate Candidate Screening

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

89 daysmedian FDA review time

223 days90th percentile

46clearances measured

K-number	Device	Applicant	Decided	Review days
K243655	TurbAlign	Spirair, Inc.	2025-07-11	227
K230142	Epi-Stop Nasal Gel/epistaxis pack	Biomed Ent, Inc.	2023-03-22	63
K213153	SPIWay Endonasal Access Guide	Spiway, LLC	2021-10-27	29
K202623	Novapak Nasal Sinus Packing and Stent	Medtronic Xomed	2020-12-08	89
K181696	ChitoZolve	Gyrus Acmi, Inc.	2018-11-30	156
K180141	SPIWay Endonasal Access Guide	Spiway, LLC	2018-02-16	29
K170913	Composite Removable Sinus Stent System	Sts Medical	2017-12-15	262
K172179	Chitogel Endoscopic Sinus Surgery Kit	Chitogel, Ltd.	2017-10-17	90
K153686	SPIWay Endonasal Access Guide	Spiway, LLC	2016-01-28	36
K141816	HEMOPORE	Polyganics B.V.,	2014-10-23	108
K141704	NOVASHIELD INJECTABLE NASAL PACKING AND STENT	Medtronic, Inc.	2014-10-06	104
K141423	NASOPORE-FD	Polyganics B.V.,	2014-08-07	69
K140992	ARTHROCARE NASASTENT CMC NASAL DRESSING	ArthroCare Corporation	2014-06-16	60
K132721	SPIWAY ENDONASAL ACCESS GUIDE	Spiway, LLC	2014-01-29	152
K130354	MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR	Entrigue Surgical, Inc.	2013-05-29	106
K122494	POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT	Hemostasis, LLC	2013-03-27	223
K113585	NASAL/EPISTAXIS PACK	Cogent Therapeutics, LLC	2012-04-25	142
K092401	SINEXUS SINUS STENT GEN 2, MODEL 1999-25	Sinexus, Inc.	2009-11-17	103
K082276	SYNTHEMED DEVICE	Synthemed, Inc.	2008-11-18	99
K080247	QUIKCLOT NOSEBLEED	Z-Medica Corporation	2008-02-27	27
K070496	ADVACOAT SINUS GEL AND STENT	Carbylan Biosurgery	2007-03-15	23
K063308	ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200	Carbylan Biosurgery	2006-12-04	32
K052099	NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ	Polyganics B.V.,	2005-11-21	110
K041381	MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT	Medtronic Xomed, Inc.	2004-09-10	108
K012532	SEPRAGEL SINUS	Genzyme Corp.	2001-10-30	85
K011544	HADGEL, 4 GRAM/SYRINGE	Seikagaku Corp.	2001-08-15	89
K002131	LACTOSORB ETHMOID STENT	Walter Lorenz Surgical, Inc.	2001-04-13	273
K981374	POREX NOSTRIL RETAINERS	Porex Surgical, Inc.	1998-07-02	77
K980221	SILIMED NASAL RETAINER	Silimed, LLC	1998-04-02	70
K972096	BIVALVE NASAL SPLINT	Boston Medical Products, Inc.	1997-07-15	41
K972092	NASAL AIRWAY SPLINT	Boston Medical Products, Inc.	1997-07-08	34
K972151	DOYLE COMBO NASAL AIRWAY SPLINT	Boston Medical Products, Inc.	1997-07-07	28
K972082	CUSTOM NASAL SPLINT	Boston Medical Products, Inc.	1997-07-03	29
K954449	ENT PACKINGS, WICKS, WIPES, AND SPONGES	Oasis	1995-11-14	81
K952226	C-FLEX SEPTAL SPLINTS	Trebay Medical Corp.	1995-08-11	91
K952207	NASAL SEPTAL SPLINT	Smith & Nephew Richards, Inc.	1995-06-07	28
K945555	NASAL SPLINT	Ultracell Medical Technologies, Inc.	1995-01-19	66
K935053	BIVONA NASAL TURBINATE STENT	Bivona Medical Technologies	1994-07-01	253
K935658	MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT	Merocel Corp.	1994-03-04	100
K933152	MEROCEL MEROSPLINT	Merocel Corp.	1993-08-17	49
K925173	BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT	Westmed Intl.	1993-01-15	93
K921202	TURBINATE NASAL SPLINT	Smith & Nephew Richards, Inc.	1992-07-23	133
K921195	NASAL SEPTAL SPLINT	Smith & Nephew Richards, Inc.	1992-07-23	133
K901307	PASSAGE AIRWAY SPLINT	Invotec International, Inc.	1990-06-14	86
K901306	INVOTEC BI-VALVE SPLINT	Invotec International, Inc.	1990-06-14	86
K830263	FLORET NASAL TAMPON	Ritmed, Inc.	1983-03-24	58

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