Cleared Traditional

THE MEDIC TM (K920912) - FDA 510(k) Clearance

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

K920912 · Medical and Environment Designs, Inc. · General Hospital
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Jul 1993
Decision
519d
Days
Class 2
Risk

K920912 is an FDA 510(k) clearance for the THE MEDIC TM. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Medical and Environment Designs, Inc. (Fenton, US). The FDA issued a Cleared decision on July 30, 1993 after a review of 519 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Medical and Environment Designs, Inc. devices

Submission Details

510(k) Number K920912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1992
Decision Date July 30, 1993
Days to Decision 519 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
390d slower than avg
Panel avg: 129d · This submission: 519d
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.

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

All 12
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K920912.
CODMAN SUCTION PATTIE
K901937 · Codman & Shurtleff, Inc. · Jul 1990
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
K893741 · Abbott Laboratories · Aug 1989
RECEPTAL SAF-GARD(TM) SYSTEM
K885208 · Abbott Laboratories · Mar 1989
VAC-RITE
K885334 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1989
PLEUR-EVAC A-4005 SYSTEM
K823037 · Howmedica Corp. · Oct 1982
THORACIC DRAINAGE SYSTEM
K821023 · Howmedica Corp. · May 1982