Cleared Traditional

K810761 - ALPHA MICRON-40 FILTER

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

K810761 · Alpha Therapeutic Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K810761

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.

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 25
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K810761.
PEDIATRIC MICROAGGREGATE BLOOD FILTER
K812874 · Abbott Laboratories · Nov 1981
HEMA 20 MICRON TRANSFUSION BLOOD FILTER
K812697 · Abbott Laboratories · Oct 1981
ULTIPOR SQ40S BLOOD TRANSFUSION FILTER
K811985 · Pall Biomedical Products Co. · Jul 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