Cleared Traditional

K823195 - GASTRIC LAVAGE KIT

K823195 is an FDA 510(k) clearance for GASTRIC LAVAGE KIT, manufactured by Autovage. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K823195 · Autovage · Gastroenterology & Urology device
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Dec 1982
Decision
38d
Days
Class 2
Risk

K823195 is an FDA 510(k) clearance for the GASTRIC LAVAGE KIT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Autovage (Walker, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 38 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Autovage devices

FDA 510(k) Submission Details - K823195

510(k) Number K823195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1982
Decision Date December 03, 1982
Days to Decision 38 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
93d faster than avg
Panel avg: 131d · This submission: 38d
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 509
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K823195.
ENTERAL SOLUTION ADMIN. PUMP SET
K830965 · Corpak Co. · Apr 1983
ARGYLE SILICONE SALEM SUMP TUBE
K830710 · Sherwood Medical Co. · Mar 1983
NEEDLE CATHETER JEJUNOSTOMY KIT
K830119 · Biosearch Medical Products, Inc. · Jan 1983
ENTERAL NUTRITION 1
K822879 · Exco, Inc. · Nov 1982
TRAVASORB NASOGASTRIC NASOINTESTINAL
K823082 · Travenol Laboratories, S.A. · Nov 1982
FACE SHIELDS
K822004 · Kelleher Corp. · Oct 1982