510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830818Substantially Equivalent

Asahi Blood/plasma Pump #Abp-01A &

Parker Hannifin Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830818 is the FDA 510(k) clearance record for ASAHI BLOOD/PLASMA PUMP #ABP-01A &, a class II device, cleared for Parker Hannifin Corp. on under FDA product code FIR (Pump, Blood, Extra-Luminal). FDA records list 14 510(k) clearances for Parker Hannifin Corp., from to . As of , FDA records show no recalls naming K830818.

Clearance record

Decision date
Received
(28 days to decision)
Product code
FIR Pump, Blood, Extra-Luminal
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Parker Hannifin Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FIR

Trailing 12 months

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

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