Cleared Traditional

K812874 - PEDIATRIC MICROAGGREGATE BLOOD FILTER

K812874 is an FDA 510(k) clearance for PEDIATRIC MICROAGGREGATE BLOOD FILTER, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code CAK cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K812874 · Abbott Laboratories · General Hospital
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Nov 1981
Decision
19d
Days
Class 2
Risk

K812874 is an FDA 510(k) clearance for the PEDIATRIC MICROAGGREGATE BLOOD FILTER. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 2, 1981 after a review of 19 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K812874

510(k) Number K812874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1981
Decision Date November 02, 1981
Days to Decision 19 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
110d faster than avg
Panel avg: 129d · This submission: 19d
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 19
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K812874.
SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE
K855064 · Cobe Laboratories, Inc. · Mar 1986
20 MICRON HIGH CAPACITY TRANS/FILTER
K830057 · Travenol Laboratories, S.A. · Jan 1983
HEMA - NV TRANS. BLOOD FILTER 100/800
K830014 · Abbott Laboratories · Jan 1983
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