Cleared Traditional

K896976 - MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS

K896976 is an FDA 510(k) clearance for MODIFIED SEPACELL R-500 AND R-500A BLOO..., manufactured by Asahi Medical Co., Ltd.. The device is a Class 2 General Hospital device with product code CAK cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K896976 · Asahi Medical Co., Ltd. · General Hospital
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Jan 1990
Decision
42d
Days
Class 2
Risk

K896976 is an FDA 510(k) clearance for the MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Asahi Medical Co., Ltd. (Washington, US). The FDA issued a Cleared decision on January 24, 1990 after a review of 42 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.

FDA 510(k) Submission Details - K896976

510(k) Number K896976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1989
Decision Date January 24, 1990
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 35
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K896976.
MODIFIED SEPACELL R-SERIES BLOOD FILTERS
K901887 · Asahi Medical Co., Ltd. · Aug 1990
SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER
K896203 · Solco Basle, Inc. · Feb 1990
MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
K896664 · Asahi Medical Co., Ltd. · Jan 1990
MICROSEPT 60/20
K890844 · Arbor Technologies, Inc. · Jun 1989
SEPACELL R-500 AND SEPACELL R-500A
K873792 · Advocacy International, Ltd. · Jan 1988
PALL LEUKOCYTE REMOVAL FILTER, BLOOD
K873666 · Pall Biomedical Products Co. · Jan 1988
K896976 · MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS
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