Cleared Traditional

K810761 - ALPHA MICRON-40 FILTER

K810761 is the FDA 510(k) clearance for ALPHA MICRON-40 FILTER by Alpha Therapeutic Corp.. It is a Class 2 General Hospital device (product code CAK) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K810761 · Alpha Therapeutic Corp. · General Hospital
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Jun 1981
Decision
102d
Days
Class 2
Risk

K810761 is an FDA 510(k) clearance for the ALPHA MICRON-40 FILTER. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Alpha Therapeutic Corp. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1981 after a review of 102 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 Alpha Therapeutic Corp. devices

Submission Details

510(k) Number K810761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1981
Decision Date June 30, 1981
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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 15
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K810761.
HEMA - NV TRANS. BLOOD FILTER 100/800
K830014 · Abbott Laboratories · Jan 1983
PEDIATRIC MICROAGGREGATE BLOOD FILTER
K812874 · Abbott Laboratories · Nov 1981
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