510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801219Substantially Equivalent

Plasmapooler

North American Biologicals, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801219 is the FDA 510(k) clearance record for PLASMAPOOLER, a class II device, cleared for North American Biologicals, Inc. on under FDA product code KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components). FDA records list 6 510(k) clearances for North American Biologicals, Inc., from to . As of , FDA records show no recalls naming K801219.

Clearance record

Decision date
Received
(163 days to decision)
Product code
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
Regulation
21 CFR 864.9100
Device class
Class II
Review panel
Hematology
Applicant
North American Biologicals, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KSR

Trailing 12 months

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

FDA records show no clearances under product code KSR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KSR, 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