Cleared Traditional

K770253 - MICROFILTRATION SET MF10

K770253 is the FDA 510(k) clearance for MICROFILTRATION SET MF10 by Biotest-Serum-Institut. It is a Class 2 General Hospital device (product code CAK) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K770253 · Biotest-Serum-Institut · General Hospital
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Apr 1977
Decision
55d
Days
Class 2
Risk

K770253 is an FDA 510(k) clearance for the MICROFILTRATION SET MF10. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Biotest-Serum-Institut (Mchenry, US). The FDA issued a Cleared decision on April 5, 1977 after a review of 55 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 Biotest-Serum-Institut devices

Submission Details

510(k) Number K770253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1977
Decision Date April 05, 1977
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 17
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K770253.
HEMA 20 MICRON TRANSFUSION BLOOD FILTER
K812697 · Abbott Laboratories · Oct 1981
INTERFACE 20 MICRON TRANSFUSION BLD. F.
K810855 · Abbott Laboratories · Apr 1981
BLOOD FILTER, MICROEMBOLI-ATS-F10
K780145 · Sorensen Research · Feb 1978
FILTER, INFUSION BLOOD (1 PFF-100)
K760165 · Bentley Laboratories, Inc. · Aug 1976
FILTER, TRANSFUSION BLOOD, INTERSEPT
K760222 · Surgikos, Inc. · Aug 1976