Cleared Traditional

K802440 - ARGYLE COMPACT CHEST DRAINAGE SYS.

K802440 is the FDA 510(k) clearance for ARGYLE COMPACT CHEST DRAINAGE SYS. by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code GCX) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K802440 · Sherwood Medical Co. · General Hospital
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Oct 1980
Decision
16d
Days
Class 2
Risk

K802440 is an FDA 510(k) clearance for the ARGYLE COMPACT CHEST DRAINAGE SYS.. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Walker, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 16 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K802440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1980
Decision Date October 23, 1980
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
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 K802440.
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
OHIO THORACIC COLLECTION UNIT
K801942 · Ohio Medical Products · Sep 1980
ARGYLE COMPACT CHEST DRAINAGE SYSTEM
K801979 · Sherwood Medical Co. · Sep 1980
TUBING, DYNACOR UNIVERSAL
K790055 · Medline Industries, Inc. · Feb 1979