510(k) Report

FDA applicant

Hemocleanse, Inc.

West Lafayette, IN5 decisions1994–19990 recalls

FDA records 5 decisions for Hemocleanse, Inc. (West Lafayette, IN) from 1994 to 1999: 5 510(k) clearances. Most are in product codes FLD (Apparatus, Hemoperfusion, Sorbent) and MLW (Warmer, Peritoneal Dialysate). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is 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 Hemocleanse, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hemocleanse, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hemocleanse, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FLDApparatus, Hemoperfusion, Sorbent3decisions
  • MLWWarmer, Peritoneal Dialysate1decision
  • KNTTubes, Gastrointestinal (And Accessories)1decision

Who builds on its devices?

Later devices cite its devices 6 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K993330Thermochem-HT SystemHemocleanse, Inc. · 19993cite it
  • K953751Biologic-DT SystemHemocleanse, Inc. · 19961cites it
  • K984546Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TKHemocleanse, Inc. · 19991cites it
  • K923046Biologic DT-1000 MachineHemocleanse, Inc. · 19941cites it

What has FDA decided for it lately?

  • K993330Thermochem-HT SystemHemocleanse, Inc. · 1999
  • K992196Biologic-DT System (Biologic-DT-1000 with DT-1000-TK)Hemocleanse, Inc. · 1999
  • K984546Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TKHemocleanse, Inc. · 1999
  • K953751Biologic-DT SystemHemocleanse, Inc. · 1996
  • K923046Biologic DT-1000 MachineHemocleanse, Inc. · 1994

All 5 as Hemocleanse, Inc. →