# K984546: Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TK

- Pathway: 510(k) (Traditional)
- Applicant: Hemocleanse, Inc.
- Decided: Aug 13, 1999 after 234 days
- Product code: FLD (Apparatus, Hemoperfusion, Sorbent)
- Device class: 2
- Regulation: 21 CFR 876.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923046 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923046: Biologic DT-1000 Machine, Hemocleanse, Inc. (1994) Summary page 1.
- K953751: Biologic-DT System, Hemocleanse, Inc. (1996) Summary page 1.

## Most influential descendants
- K113313: Molecular Adsorbent Recirculating (Mars) (2012), 0 descendants of its own

## Indications for use
1) Acute Hepatic Encephalopathy: The BioLogic-DT System is indicated for the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure. 2) Drug Overdose and Poisonings: The BioLogic-DT System is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal, such as acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents, antimicrobials, theophylline, herbicides, and insecticides. Contraindication: The BioLogic-DT is not indicated for the treatment of chronic liver conditions or as a bridge to liver transplant.

Source page: https://510kreport.com/device/K984546
Methodology: https://510kreport.com/methodology