Cleared Traditional

SEPACELL R-500 & SEPACELL R-500A (K854259) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854259 · Advocacy International, Ltd. · General Hospital
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Jan 1986
Decision
77d
Days
Class 2
Risk

K854259 is an FDA 510(k) clearance for the SEPACELL R-500 & SEPACELL R-500A. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Advocacy International, Ltd. (Washington, US). The FDA issued a Cleared decision on January 8, 1986 after a review of 77 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 Advocacy International, Ltd. devices

Submission Details

510(k) Number K854259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1985
Decision Date January 08, 1986
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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 35
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K854259.
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
K982822 · Baxter Healthcare Corp · Sep 1998
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
20 MICRON HIGH CAPACITY TRANS/FILTER
K830057 · Travenol Laboratories, S.A. · Jan 1983