# K992196: Biologic-DT System (Biologic-DT-1000 with DT-1000-TK)

- Pathway: 510(k) (Special)
- Applicant: Hemocleanse, Inc.
- Decided: Sep 10, 1999 after 72 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1) Acute Hepatic Encephalopathy: The BioLogic-DT System is indicatd 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/K992196
Methodology: https://510kreport.com/methodology