Cleared Special

K033936 - BARD ELIMINATOR PET BALLOON DILATORS

K033936 is an FDA 510(k) clearance for BARD ELIMINATOR PET BALLOON DILATORS, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Special 510(k) pathway after a 26-day FDA review.

K033936 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
26d
Days
Class 2
Risk

K033936 is an FDA 510(k) clearance for the BARD ELIMINATOR PET BALLOON DILATORS. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on January 14, 2004 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033936

510(k) Number K033936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2003
Decision Date January 14, 2004
Days to Decision 26 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 131d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

KNQ Device Classification - Class 2, Special Controls

Product Code KNQ Dilator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNQ Dilator, Esophageal

All 39
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K033936.
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · Boston Scientific Corp · Sep 2006
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
K060302 · Cordis Europa, N.V. · Apr 2006
INSCOPE 3-STAGE BALLOON DILATOR
K043605 · Cordis Europa, N.V. · Feb 2005
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
K031147 · Ethicon Endo-Surgery, Inc. · Jan 2004
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
K023907 · Cordis Corp. · Dec 2002
MEDOVATIONS ESOPHAGEAL DILATOR
K002363 · Medovations, Inc. · Nov 2000
K033936 · BARD ELIMINATOR PET BALLOON DILATORS
Download PDF FDA Summary C.R. Bard, Inc.