Cleared Special

BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT (K993138) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K993138 · Ballard Medical Products · Gastroenterology & Urology device
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Oct 1999
Decision
30d
Days
Class 2
Risk

K993138 is an FDA 510(k) clearance for the BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Ballard Medical Products (Draper, US). The FDA issued a Cleared decision on October 20, 1999 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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.

View all Ballard Medical Products devices

Submission Details

510(k) Number K993138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1999
Decision Date October 20, 1999
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 142
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K993138.
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
K020120 · Boston Scientific Corp · Aug 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
K014297 · Boston Scientific Corp · Jul 2002
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · C.R. Bard, Inc. · Oct 2001
BARD BALLOON INFLATION SYSTEM
K991375 · C.R. Bard, Inc. · Sep 1999
CHAIT CECOSTOMY CATHETER
K982500 · Cook, Inc. · Jan 1999
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554 · Abbott Laboratories · Nov 1997