Cleared Traditional

K896203 - SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER

K896203 is an FDA 510(k) clearance for SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER, manufactured by Solco Basle, Inc.. The device is a Class 2 General Hospital device with product code CAK cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K896203 · Solco Basle, Inc. · General Hospital
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Feb 1990
Decision
98d
Days
Class 2
Risk

K896203 is an FDA 510(k) clearance for the SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Solco Basle, Inc. (Hingham, US). The FDA issued a Cleared decision on February 1, 1990 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Solco Basle, Inc. devices

FDA 510(k) Submission Details - K896203

510(k) Number K896203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1989
Decision Date February 01, 1990
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAK Device Classification - Class 2, Special Controls

Product Code CAK Microfilter, Blood Transfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - CAK Microfilter, Blood Transfusion

All 25
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K896203.
ALPHA MICRON 20 MICROAGGREGATE FILTER
K955515 · Alpha Therapeutic Corp. · Feb 1996
SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS
K904221 · Baxter Healthcare Corp · Oct 1990
SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS
K904223 · Baxter Healthcare Corp · Oct 1990
PALL LEUKOCYTE REMOVAL FILTER, BLOOD
K873666 · Pall Biomedical Products Co. · Jan 1988
PALL LEUKOCYTE REMOVAL FILTER, PLATELETS
K873667 · Pall Biomedical Products Co. · Jan 1988
RESUBMITTED MICRON TRANSFUSION FILTER
K873873 · Travenol Laboratories, S.A. · Oct 1987