Cleared Traditional

K946140 - PRG BUTTON

K946140 is an FDA 510(k) clearance for PRG BUTTON, manufactured by Applied Medical Technologies. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K946140 · Applied Medical Technologies · Gastroenterology & Urology device
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Aug 1995
Decision
255d
Days
Class 2
Risk

K946140 is an FDA 510(k) clearance for the PRG BUTTON. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Applied Medical Technologies (Independence, US). The FDA issued a Cleared decision on August 28, 1995 after a review of 255 days - an extended review cycle.

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 Applied Medical Technologies devices

FDA 510(k) Submission Details - K946140

510(k) Number K946140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1994
Decision Date August 28, 1995
Days to Decision 255 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
124d slower than avg
Panel avg: 131d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 489
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K946140.
LOW PROFILE CATHETER
K922567 · Rusch, Inc. · Nov 1995
GASTROINTESTINAL TUBES & ACCESSORIES
K945618 · Applied Medical Technologies · Oct 1995
ENDOLUMINAL ACCESS TUBE
K941228 · Med Institute, Inc. · Sep 1995
HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE
K953232 · Hollister, Inc. · Aug 1995
GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY
K923488 · Applied Medical Technologies · Jul 1995
CORPAK GASTROSTOMY TUBE
K931921 · Corpak Co. · Jun 1995