510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961137Substantially Equivalent

Ati Plasma Pump (Pp-04)

Apheresis Technologies, Inc., Palm Harbor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961137 is the FDA 510(k) clearance record for ATI PLASMA PUMP (PP-04), a class II device, cleared for Apheresis Technologies, Inc. on under FDA product code FIR (Pump, Blood, Extra-Luminal). FDA records list 2 510(k) clearances for Apheresis Technologies, Inc., from to . As of , FDA records show 2 recalls naming K961137.

Clearance record

Decision date
Received
(85 days to decision)
Product code
FIR Pump, Blood, Extra-Luminal
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Apheresis Technologies, Inc. 612 Florida Ave., Palm Harbor FL
510(k) summary
Statement
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