Cleared Traditional

K896203 - SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER

K896203 is the FDA 510(k) clearance for SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER by Solco Basle, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 12
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K896203.
FENWAL 40 MICRON TRANSFUSION FILTER
K972159 · Baxter Healthcare Corp · Jul 1997
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
RESUBMITTED MICRON TRANSFUSION FILTER
K873873 · Travenol Laboratories, S.A. · Oct 1987
ERYPUR B
K864636 · Organon Teknika Corp. · Jan 1987
SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE
K855064 · Cobe Laboratories, Inc. · Mar 1986