Cleared Traditional

K823037 - PLEUR-EVAC A-4005 SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K823037 · Howmedica Corp. · General Hospital
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Oct 1982
Decision
14d
Days
Class 2
Risk

K823037 is an FDA 510(k) clearance for the PLEUR-EVAC A-4005 SYSTEM. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Howmedica Corp. (Walker, US). The FDA issued a Cleared decision on October 28, 1982 after a review of 14 days - a notably fast clearance cycle.

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: 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 Howmedica Corp. devices

Submission Details

510(k) Number K823037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1982
Decision Date October 28, 1982
Days to Decision 14 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
114d faster than avg
Panel avg: 128d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.