Cleared Traditional

K855064 - SWANK BLOOD TRANSFUSION MICRO-FILTER W/...

K855064 is the FDA 510(k) clearance for SWANK BLOOD TRANSFUSION MICRO-FILTER W/... by Cobe Laboratories, Inc.. It is a Class 2 General Hospital device (product code CAK) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K855064 · Cobe Laboratories, Inc. · General Hospital
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Mar 1986
Decision
84d
Days
Class 2
Risk

K855064 is an FDA 510(k) clearance for the SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 84 days - a notably fast clearance cycle.

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: 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 Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K855064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1985
Decision Date March 12, 1986
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 11
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K855064.
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
20 MICRON HIGH CAPACITY TRANS/FILTER
K830057 · Travenol Laboratories, S.A. · Jan 1983
HEMA - NV TRANS. BLOOD FILTER 100/800
K830014 · Abbott Laboratories · Jan 1983
PEDIATRIC MICROAGGREGATE BLOOD FILTER
K812874 · Abbott Laboratories · Nov 1981