Cleared Traditional

K822318 - ARGYLE MEDIASTINAL DRAIN

K822318 is an FDA 510(k) clearance for ARGYLE MEDIASTINAL DRAIN, manufactured by Sherwood Medical Co.. The device is a Class 1 General & Plastic Surgery device with product code GBS cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K822318 · Sherwood Medical Co. · General & Plastic Surgery device
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Aug 1982
Decision
24d
Days
Class 1
Risk

K822318 is an FDA 510(k) clearance for the ARGYLE MEDIASTINAL DRAIN. Classified as Catheter, Ventricular, General & Plastic Surgery (product code GBS), Class I - General Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1982 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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

FDA 510(k) Submission Details - K822318

510(k) Number K822318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1982
Decision Date August 27, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
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: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

GBS Device Classification - Class 1, General Controls

Product Code GBS Catheter, Ventricular, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBS Catheter, Ventricular, General & Plastic Surgery

All 19
Devices cleared under the same product code (GBS) and FDA review panel - the closest regulatory comparables to K822318.
AXIOM ATRAUM TROCAR CATHETER
K852241 · Axiom Medical, Inc. · Jun 1985
CHEST CATHETERS/THORACIC CATHETERS
K851048 · Medovations, Inc. · Jun 1985
AXIOM HYDROMER WOUND DRAINS
K832416 · Axiom Medical, Inc. · Oct 1983
SIL-V-UR CHEST CATHETER
K813463 · C.R. Bard, Inc. · Feb 1982
DISPOSABLE THORACIC CATHETER
K813587 · Texas Medical Products, Inc. · Jan 1982
DAVOL SILICONE SHEATH SUMP DRAIN
K810158 · C.R. Bard, Inc. · Feb 1981