Cleared Special

K993138 - BALLARD MIC-KEY G LOW PROFILE GASTROSTO...

K993138 is an FDA 510(k) clearance for BALLARD MIC-KEY G LOW PROFILE GASTROSTO..., manufactured by Ballard Medical Products. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Special 510(k) pathway after a 30-day FDA review.

K993138 · Ballard Medical Products · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K993138

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

KNT Device Classification - Class 2, Special Controls

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 344
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K993138.
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K992181 · Datex-Ohmeda, Inc. · Aug 1999
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K982500 · Cook, Inc. · Jan 1999