Cleared Traditional

K810392 - OESOPHAGEAL THERAPY KIT

K810392 is the FDA 510(k) clearance for OESOPHAGEAL THERAPY KIT by Keymed, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K810392 · Keymed, Inc. · Gastroenterology & Urology device
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Mar 1981
Decision
42d
Days
Class 2
Risk

K810392 is an FDA 510(k) clearance for the OESOPHAGEAL THERAPY KIT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Keymed, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1981 after a review of 42 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 Keymed, Inc. devices

Submission Details

510(k) Number K810392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1981
Decision Date March 31, 1981
Days to Decision 42 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 130d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 291
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K810392.
ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT
K810979 · Arrow Intl., Inc. · Jun 1981
ENTERNAL PUMP SET W/INTEGRAL CONTAINER
K810996 · Abbott Laboratories · Apr 1981
KANGAROO NASOGASTRIC FEEDING TUBE
K810854 · Chesebrough-Pond'S U.S.A. Co. · Apr 1981
ARGYLE SALEM SUMP TUBE
K810156 · Sherwood Medical Co. · Mar 1981
FEEDING TUBES IN SILICONE 5,6,8&10 SIZES
K802585 · The Healthcare Group Laboratories, Inc. · Oct 1980
ENTRI NASOGASTRIC FEEDING TUBE
K801498 · Biosearch Medical Products, Inc. · Jul 1980