Cleared Traditional

K991375 - BARD BALLOON INFLATION SYSTEM

K991375 is the FDA 510(k) clearance for BARD BALLOON INFLATION SYSTEM by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K991375 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Sep 1999
Decision
142d
Days
Class 2
Risk

K991375 is an FDA 510(k) clearance for the BARD BALLOON INFLATION SYSTEM. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on September 10, 1999 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K991375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1999
Decision Date September 10, 1999
Days to Decision 142 days
Submission Type Traditional
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
12d slower than avg
Panel avg: 130d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 252
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K991375.
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH
K013162 · Medcomp · Oct 2001
TRIP TONOMETRY CATHETER, 14F
K993296 · Datex-Ohmeda, Inc. · Dec 1999
NUTRISAFE EXTENSION TUBE
K991918 · Vygon Corp. · Oct 1999
TRIP TONOMETRY CATHETER, 8F
K992181 · Datex-Ohmeda, Inc. · Aug 1999
CHAIT CECOSTOMY CATHETER
K982500 · Cook, Inc. · Jan 1999
RUSCH BLAKEMORE 3 LUMEN, STERILE
K981203 · Rusch Intl. · Jun 1998