Cleared Traditional

K812102 - O.N.A.T.

K812102 is an FDA 510(k) clearance for O.N.A.T., manufactured by Latex Medical Devices, Inc.. 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.

K812102 · Latex Medical Devices, Inc. · Gastroenterology & Urology device
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Aug 1981
Decision
38d
Days
Class 2
Risk

K812102 is an FDA 510(k) clearance for the O.N.A.T.. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Latex Medical Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 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 Latex Medical Devices, Inc. devices

FDA 510(k) Submission Details - K812102

510(k) Number K812102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1981
Decision Date August 31, 1981
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
92d faster than avg
Panel avg: 130d · 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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K812102.
ARGYLE INDWELL FEEDING TUBE
K820442 · Sherwood Medical Co. · Mar 1982
CELESTIN PULSION ESOPHOGEAL PROSTHESIS
K813169 · Inmed Corp. · Dec 1981
CARTMILL/BARRY FEEDING TUBE
K812427 · Impra, Inc. · Sep 1981
ENTER-A1 ENTERIC FEEDING TUBE
K812279 · Medi-Tech, Inc. · Aug 1981
ENTRI ENTERNAL FEEDING SET
K811683 · Biosearch Medical Products, Inc. · Jul 1981
ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT
K810979 · Arrow Intl., Inc. · Jun 1981