# Hemocleanse, Inc.

- Location (FDA's records): West Lafayette, IN
- FDA decisions: 5 (1994–1999): 5 510(k) clearances
- Product codes: FLD (3), MLW (1), KNT (1)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Thermal Therapeutic Systems, Inc.: 1 (https://510kreport.com/company/thermal-therapeutic-systems)
- Gambro Renal Products: 1 (https://510kreport.com/company/gambro-renal-products)
- Belmont Instrument Corp.: 1 (https://510kreport.com/company/belmont-instrument)
- Thermasolutions, LLC: 1 (https://510kreport.com/company/thermasolutions)

## Its most-cited devices
- K993330: Thermochem-HT System (1999), cited by 3
- K953751: Biologic-DT System (1996), cited by 1
- K984546: Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TK (1999), cited by 1
- K923046: Biologic DT-1000 Machine (1994), cited by 1

## Recent decisions
- K993330: Thermochem-HT System (Dec 30, 1999)
- K992196: Biologic-DT System (Biologic-DT-1000 with DT-1000-TK) (Sep 10, 1999)
- K984546: Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TK (Aug 13, 1999)
- K953751: Biologic-DT System (Feb 15, 1996)
- K923046: Biologic DT-1000 Machine (Sep 30, 1994)

Source page: https://510kreport.com/company/hemocleanse