510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820301Substantially Equivalent

Plasma Pooler Heat Sealer

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

K820301 is the FDA 510(k) clearance record for PLASMA POOLER HEAT SEALER, a class I device, cleared for North American Biologicals, Inc. on under FDA product code KSD (Device, Heat-Sealing). FDA records list 6 510(k) clearances for North American Biologicals, Inc., from to . As of , FDA records show no recalls naming K820301.

Clearance record

Decision date
Received
(64 days to decision)
Product code
KSD Device, Heat-Sealing
Regulation
21 CFR 864.9750
Device class
Class I
Review panel
Hematology
Applicant
North American Biologicals, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KSD

Trailing 12 months

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

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