510(k) Report

FDA applicant

Apheresis Technologies, Inc.

Palm Harbor, FL2 decisions1993–19962 recalls

FDA records 2 decisions for Apheresis Technologies, Inc. (Palm Harbor, FL) from 1993 to 1996: 2 510(k) clearances. Most are in product codes LKN (Separator, Automated, Blood Cell And Plasma…) and FIR (Pump, Blood, Extra-Luminal). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Apheresis Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Apheresis Technologies, Inc. since 2007.

Recalls per year

1in 2012

2009: 12012: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Apheresis Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic1decision
  • FIRPump, Blood, Extra-Luminal1decision

What has FDA decided for it lately?

  • K961137Ati Plasma Pump (PP-04)Apheresis Technologies, Inc. · 19962 recalls
  • K926409Plasma Discard BagsApheresis Technologies, Inc. · 1993

All 2 as Apheresis Technologies, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K961137Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange…Jul 9, 2012Class II
  • K961137Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis…Apr 1, 2009