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IBM 2991 Blood Cell Processor Mod. 1 & 2

by Intl. Business Machines

510(k) K812355

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812355 Date9 Sep 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAC
Device Class
Class II
Regulation
21 CFR Part 868.5830
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IBM 2991 Blood Cell Processor Mod. 1 & 2 is an Apparatus, Autotransfusion designed for the automated washing and separation of blood cells. It is specifically intended for removing glycerol preservatives from frozen and thawed red blood cells, facilitating safer and more stable storage for transfusion purposes. This device supports blood processing procedures by mechanically separating cellular components from plasma and glycerol, ensuring compatibility for clinical use.

This device is supplied as a reusable medical instrument and is classified under FDA regulation 868.5830 as a Class II device. It was granted FDA 510K clearance (K812355) in 1981, with the submission reviewed by the Anesthesiology Advisory Committee. The processor operates in clinical settings, such as blood banks and transfusion centers, and requires proper maintenance and sterilization between uses. No MRI safety information is provided in the specifications.

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