Cleared Traditional

K821023 - THORACIC DRAINAGE SYSTEM

K821023 is the FDA 510(k) clearance for THORACIC DRAINAGE SYSTEM by Howmedica Corp.. It is a Class 2 General Hospital device (product code GCX) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K821023 · Howmedica Corp. · General Hospital
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May 1982
Decision
38d
Days
Class 2
Risk

K821023 is an FDA 510(k) clearance for the THORACIC DRAINAGE 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 May 21, 1982 after a review of 38 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 K821023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1982
Decision Date May 21, 1982
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
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 39
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K821023.
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
SURGICAL SUCTION INSTRUMENTS-DISPOS.
K812845 · Abco Dealers, Inc. · Nov 1981
ARGYLE YANKAUER SUCTION TUBE
K813066 · Sherwood Medical Co. · Nov 1981
ARGYLE COMPACT CHEST DRAINAGE SYS.
K802440 · Sherwood Medical Co. · Oct 1980