Cleared Traditional

K872590 - SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSI...

K872590 is the FDA 510(k) clearance for SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSI... by Solco Basle, Inc.. It is a Class 2 Anesthesiology device (product code CAC) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K872590 · Solco Basle, Inc. · Anesthesiology device
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Sep 1987
Decision
65d
Days
Class 2
Risk

K872590 is an FDA 510(k) clearance for the SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Solco Basle, Inc. (Rockland, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - the FDA anesthesiology and respiratory 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 Solco Basle, Inc. devices

Submission Details

510(k) Number K872590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1987
Decision Date September 04, 1987
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAC Apparatus, Autotransfusion

All 47
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K872590.
DIDECO-SHILEY AUTOTRANS BT 795/AA
K881683 · Shiley, Inc. · Jun 1988
DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK
K881421 · Shiley, Inc. · May 1988
DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT
K872927 · C.R. Bard, Inc. · Oct 1987
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE)
K872814 · Shiley, Inc. · Aug 1987
DIDECO-SHILEY BLOOD SEPARATION WASH BOWL
K872160 · Shiley, Inc. · Jul 1987
DIDECO-SHILEY WASTE COLLECTION BAG
K872158 · Shiley, Inc. · Jul 1987