Cleared Traditional

K812355 - IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2

K812355 is the FDA 510(k) clearance for IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 by Intl. Business Machines. It is a Class 2 Hematology device (product code CAC) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K812355 · Intl. Business Machines · Hematology device
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Sep 1981
Decision
21d
Days
Class 2
Risk

K812355 is an FDA 510(k) clearance for the IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Intl. Business Machines (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 868.5830 - the FDA hematology 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 Intl. Business Machines devices

Submission Details

510(k) Number K812355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1981
Decision Date September 09, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 113d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 Hematology devices follow this clearance model.

Regulatory Peers - CAC Apparatus, Autotransfusion

All 126
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K812355.
PLEURAL DRAINAGE SYS #PDS-100-4
K831849 · American Bentley · Dec 1983
BT 795/A AUTOTRANS
K830735 · Electromedics, Inc. · May 1983
AUTOTRANS BT795
K812292 · Electromedics, Inc. · Oct 1981
SORENSON CATALOG #IFL-120S
K811228 · Sorensen Research · Jun 1981
TRAUMA DRAINAGE SET 72T-28TTC
K781550 · Sorensen Research · Oct 1978
TRAUMA DRAINAGE SET 72T-32TTC
K781551 · Sorensen Research · Oct 1978