Cleared Traditional

K832170 - MUFFLER GAS-AIR VENT UNIT

K832170 is an FDA 510(k) clearance for MUFFLER GAS-AIR VENT UNIT, manufactured by Dr. Edward Richards. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 636-day FDA review.

K832170 · Dr. Edward Richards · Gastroenterology & Urology device
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Apr 1985
Decision
636d
Days
Class 2
Risk

K832170 is an FDA 510(k) clearance for the MUFFLER GAS-AIR VENT UNIT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Dr. Edward Richards (Walker, US). The FDA issued a Cleared decision on April 2, 1985 after a review of 636 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Dr. Edward Richards devices

FDA 510(k) Submission Details - K832170

510(k) Number K832170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1983
Decision Date April 02, 1985
Days to Decision 636 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
506d slower than avg
Panel avg: 130d · This submission: 636d
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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K832170.
ENDO-TUBE
K850664 · Biosearch Medical Products, Inc. · Jun 1985
GASTROINTESTINAL TUBE
K851671 · Sheridan Catheter Corp. · Jun 1985
CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO
K851539 · Chesebrough-Pond'S U.S.A. Co. · Jun 1985
IVAC KEOFEED II POLYURETHANE FEEDING TUBE
K850182 · Y · Mar 1985
KANGAROO NASOGASTRIC FEEDING TUBE
K843567 · Chesebrough-Pond'S U.S.A. Co. · Feb 1985
ENTRON ENTERAL FEEDING BAG
K850134 · Biosearch Medical Products, Inc. · Feb 1985