Cleared Traditional

K851444 - KEITH-A.R.V.

K851444 is an FDA 510(k) clearance for KEITH-A.R.V., manufactured by Karl M. Block Co.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K851444 · Karl M. Block Co. · Gastroenterology & Urology device
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May 1985
Decision
29d
Days
Class 2
Risk

K851444 is an FDA 510(k) clearance for the KEITH-A.R.V.. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Karl M. Block Co. (St. Louis, US). The FDA issued a Cleared decision on May 10, 1985 after a review of 29 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 Karl M. Block Co. devices

FDA 510(k) Submission Details - K851444

510(k) Number K851444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1985
Decision Date May 10, 1985
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
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 K851444.
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