Cleared Traditional

K831116 - INVAC W/VARIOUS MODELS

K831116 is an FDA 510(k) clearance for INVAC W/VARIOUS MODELS, manufactured by Pmt. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K831116 · Pmt · General Hospital
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Aug 1983
Decision
129d
Days
Class 2
Risk

K831116 is an FDA 510(k) clearance for the INVAC W/VARIOUS MODELS. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Pmt (Hopkins, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 129 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K831116

510(k) Number K831116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1983
Decision Date August 12, 1983
Days to Decision 129 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 129d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 58
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K831116.
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K833673 · Sorensen Research · Dec 1983
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PLEUR-EVAC A-4005 SYSTEM
K823037 · Howmedica Corp. · Oct 1982
DISPOSABLE COLLECTION BOTTLE W/TUBING
K822311 · Ohio Medical Products · Aug 1982