Atlas FDA

KNQ

40 FDA 510(k) clearances · Product code

88 daysmedian time to decision
325 days90th percentile
40clearances measured

FDA profile

Official device name
Dilator, Esophageal
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5365
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 351 · 2022: 274 · 2023: 319 · 2024: 268 · 2025: 284 · 2026: 207
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CRE FIXED WIRE BALLON DILATION CATHETER (K122924)Boston Scientific Corp2012-10-24
ETHICON ENDO-SURGERYOPTICAL DILATOR (K093236)Ethicon Endo-Surgery, Inc.2009-11-10
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON (K090183)Cook Endoscopy2009-09-25
SMART DILATOR (K082995)Safestitch Medical2009-02-06
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON (K061937)Cook Endoscopy2006-12-01
MAXFORCE TTS SINGLE-USE BALLOON DILATOR (K061787)Boston Scientific Corp2006-09-21
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED (K060302)Cordis Europa, N.V.2006-04-11
INSCOPE 3-STAGE BALLOON DILATOR (K043605)Cordis Europa, N.V.2005-02-04
BARD ELIMINATOR PET BALLOON DILATORS (K033936)C.R. Bard, Inc.2004-01-14
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR (K031147)Ethicon Endo-Surgery, Inc.2004-01-12
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER (K023907)Cordis Corp.2002-12-18
MEDOVATIONS ESOPHAGEAL DILATOR (K002363)Medovations, Inc.2000-11-01
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER (K993720)Cordis Corp.2000-01-18
IMPACT BALLOON DILATION CATHETER (K983373)B. Braun/Mcgaw1999-06-22
JACKSON ESOPHAGEAL DILATOR (K990935)Pilling Weck Surgical1999-05-17
CRE(TM) BALLOON DILATATION CATHETER (K974788)Boston Scientific Corp1998-03-20
CRE BALLOON DILATATION CATHETER (K971320)Boston Scientific Corp1997-10-09
PATTISON ESOPHAGEAL DILATOR (K971615)Tri-Med Specialties, Inc.1997-07-24
BALLON DILATATION CATHETER (K961438)Boston Scientific Corp1996-07-31
XXL BALLOON DILATATION CATHETER (K952656)Boston Scientific Corp1995-07-19
OVER THE GUIDEWIRE DILATATION SYSTEM (K924646)Medovations, Inc.1994-12-05
WILSON-COOK BALLOON INFLATION DEVICE (K933845)Wilson-Cook Medical, Inc.1994-11-29
MICROVASIVE MAXFORCE (K934697)Boston Scientific Corp1994-05-16
TRI-MED INFLATABLE ESOPHAGEAL DILATOR (K932015)Tri-Med Specialties, Inc.1994-02-03
OLYMPUS SCLEROTHERAPY BALLOON (K933992)Olympus Corp.1993-12-21
FLEX-TECH BALLOON DILATOR (K926038)Cape Tech Medical Products1993-10-25
WILSON-COOK BALLOON DILATION CATHETERS (K900924)Wilson-Cook Medical, Inc.1990-12-21
ESOPHAGEAL BALLOON DILATOR (K901424)Telemed Systems, Inc.1990-06-21
ACHELASIA BALLOON DIALATOR (K884715)Primrose Medical, Inc.1989-09-29
ESOPHAGEAL AND PYLORIC BALLOON DIALATORS (K884712)Primrose Medical, Inc.1989-09-08
PORGES STEPPED NEOPLEX DILATOR (K883526)Porges Corp.1988-10-28
MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS (K881478)Keymed (Medical & Industrial Equipment), Ltd.1988-09-14
KEYMED FLEXIBLE ESOPHAGEAL DILATORS (K862000)Keymed, Inc.1986-08-12
AMERICAN DILATATION SYSTEM (K853274)American Endoscopy, Inc.1985-10-17
SAVARY-GILLIARD DILATOR (K851955)Wilson-Cook Medical, Inc.1985-07-25
GASTROINTESTINAL DILATOR (K841310)Thomas J. Fogarty, M.D.1984-07-31
COAXIAL BALLOON GASTROESOPHAGEAL DILA (K834451)Thomas J. Fogarty, M.D.1984-02-04
ESOPHAGEAL BOUGIES (K830991)Medovations, Inc.1983-06-02
TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR (K830586)Keymed, Inc.1983-03-24
CELESTIN DILATOR (K812289)Inmed Corp.1981-09-01

Track KNQ automatically

Every clearance here is in the API, with alerts when new ones post.