510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K831004Substantially Equivalent

Automated 8400 Blood Cell Separator

Intl. Business Machines, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831004 is the FDA 510(k) clearance record for AUTOMATED 8400 BLOOD CELL SEPARATOR, cleared for Intl. Business Machines on under FDA product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic). FDA records list 8 510(k) clearances for Intl. Business Machines, from to . As of , FDA records show no recalls naming K831004.

Clearance record

Decision date
Received
(167 days to decision)
Product code
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Device class
Unclassified
Review panel
Unknown
Applicant
Intl. Business Machines 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LKN

Trailing 12 months

FDA records hold no clearances under product code LKN in the trailing twelve months.

FDA records show no clearances under product code LKN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260