Cleared Traditional

K821841 - MEDIGAS SUCTION/DRAINAGE EQUIPMENT

K821841 is an FDA 510(k) clearance for MEDIGAS SUCTION/DRAINAGE EQUIPMENT, manufactured by Linde Div. Union Carbide Corp.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K821841 · Linde Div. Union Carbide Corp. · General Hospital
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Jul 1982
Decision
10d
Days
Class 2
Risk

K821841 is an FDA 510(k) clearance for the MEDIGAS SUCTION/DRAINAGE EQUIPMENT. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Linde Div. Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 10 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 Linde Div. Union Carbide Corp. devices

FDA 510(k) Submission Details - K821841

510(k) Number K821841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1982
Decision Date July 02, 1982
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
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 47
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K821841.
PLEUR-EVAC A-4005 SYSTEM
K823037 · Howmedica Corp. · Oct 1982
DISPOSABLE COLLECTION BOTTLE W/TUBING
K822311 · Ohio Medical Products · Aug 1982
SPECIMEN COLLECTORS
K822005 · Kelleher Corp. · Jul 1982
THORACIC DRAINAGE SYSTEM
K821023 · Howmedica Corp. · May 1982
SURGICAL SUCTION INSTRUMENTS-DISPOS.
K812845 · Abco Dealers, Inc. · Nov 1981
ARGYLE YANKAUER SUCTION TUBE
K813066 · Sherwood Medical Co. · Nov 1981