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

KNQ — Predicate Candidate Screening

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

88 daysmedian FDA review time

325 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K122924	CRE FIXED WIRE BALLON DILATION CATHETER	Boston Scientific Corp	2012-10-24	30	0
K093236	ETHICON ENDO-SURGERYOPTICAL DILATOR	Ethicon Endo-Surgery, Inc.	2009-11-10	26	0
K090183	HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON	Cook Endoscopy	2009-09-25	242	0
K082995	SMART DILATOR	Safestitch Medical	2009-02-06	121	0
K061937	COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON	Cook Endoscopy	2006-12-01	144	0
K061787	MAXFORCE TTS SINGLE-USE BALLOON DILATOR	Boston Scientific Corp	2006-09-21	87	0
K060302	INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED	Cordis Europa, N.V.	2006-04-11	64	0
K043605	INSCOPE 3-STAGE BALLOON DILATOR	Cordis Europa, N.V.	2005-02-04	36	0
K033936	BARD ELIMINATOR PET BALLOON DILATORS	C.R. Bard, Inc.	2004-01-14	26	13
K031147	OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR	Ethicon Endo-Surgery, Inc.	2004-01-12	277	0
K023907	CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, C	Cordis Corp.	2002-12-18	23	0
K002363	MEDOVATIONS ESOPHAGEAL DILATOR	Medovations, Inc.	2000-11-01	90	0
K993720	CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER	Cordis Corp.	2000-01-18	76	0
K983373	IMPACT BALLOON DILATION CATHETER	B. Braun/Mcgaw	1999-06-22	271	1
K990935	JACKSON ESOPHAGEAL DILATOR	Pilling Weck Surgical	1999-05-17	59	0
K974788	CRE(TM) BALLOON DILATATION CATHETER	Boston Scientific Corp	1998-03-20	88	0
K971320	CRE BALLOON DILATATION CATHETER	Boston Scientific Corp	1997-10-09	182	0
K971615	PATTISON ESOPHAGEAL DILATOR	Tri-Med Specialties, Inc.	1997-07-24	83	0
K961438	BALLON DILATATION CATHETER	Boston Scientific Corp	1996-07-31	107	0
K952656	XXL BALLOON DILATATION CATHETER	Boston Scientific Corp	1995-07-19	72	0
K924646	OVER THE GUIDEWIRE DILATATION SYSTEM	Medovations, Inc.	1994-12-05	812	0
K933845	WILSON-COOK BALLOON INFLATION DEVICE	Wilson-Cook Medical, Inc.	1994-11-29	480	0
K934697	MICROVASIVE MAXFORCE	Boston Scientific Corp	1994-05-16	228	1
K932015	TRI-MED INFLATABLE ESOPHAGEAL DILATOR	Tri-Med Specialties, Inc.	1994-02-03	286	0
K933992	OLYMPUS SCLEROTHERAPY BALLOON	Olympus Corp.	1993-12-21	126	0
K926038	FLEX-TECH BALLOON DILATOR	Cape Tech Medical Products	1993-10-25	328	0
K900924	WILSON-COOK BALLOON DILATION CATHETERS	Wilson-Cook Medical, Inc.	1990-12-21	297	0
K901424	ESOPHAGEAL BALLOON DILATOR	Telemed Systems, Inc.	1990-06-21	87	0
K884715	ACHELASIA BALLOON DIALATOR	Primrose Medical, Inc.	1989-09-29	325	0
K884712	ESOPHAGEAL AND PYLORIC BALLOON DIALATORS	Primrose Medical, Inc.	1989-09-08	304	0
K883526	PORGES STEPPED NEOPLEX DILATOR	Porges Corp.	1988-10-28	71	0
K881478	MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS	Keymed (Medical & Industrial Equipment), Ltd.	1988-09-14	161	0
K862000	KEYMED FLEXIBLE ESOPHAGEAL DILATORS	Keymed, Inc.	1986-08-12	81	0
K853274	AMERICAN DILATATION SYSTEM	American Endoscopy, Inc.	1985-10-17	73	0
K851955	SAVARY-GILLIARD DILATOR	Wilson-Cook Medical, Inc.	1985-07-25	83	1
K841310	GASTROINTESTINAL DILATOR	Thomas J. Fogarty, M.D.	1984-07-31	123	0
K834451	COAXIAL BALLOON GASTROESOPHAGEAL DILA	Thomas J. Fogarty, M.D.	1984-02-04	47	0
K830991	ESOPHAGEAL BOUGIES	Medovations, Inc.	1983-06-02	65	0
K830586	TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR	Keymed, Inc.	1983-03-24	29	0
K812289	CELESTIN DILATOR	Inmed Corp.	1981-09-01	19	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