Cleared Traditional

K822516 - VIVONEX MASS GASTRASTOMY TUBE

K822516 is an FDA 510(k) clearance for VIVONEX MASS GASTRASTOMY TUBE, manufactured by Norwich Eaton Pharmaceuticals, Inc.. The device is a Class 1 Immunology device with product code KHT cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K822516 · Norwich Eaton Pharmaceuticals, Inc. · Immunology device
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Sep 1982
Decision
18d
Days
Class 1
Risk

K822516 is an FDA 510(k) clearance for the VIVONEX MASS GASTRASTOMY TUBE. Classified as Fraction V, Antigen, Antiserum, Control (product code KHT), Class I - General Controls.

Submitted by Norwich Eaton Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1982 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5370 - the FDA immunology 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.

FDA 510(k) Submission Details - K822516

510(k) Number K822516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1982
Decision Date September 07, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 105d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

KHT Device Classification - Class 1, General Controls

Product Code KHT Fraction V, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5370
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.