# K923046: Biologic DT-1000 Machine

- Pathway: 510(k) (Traditional)
- Applicant: Hemocleanse, Inc.
- Decided: Sep 30, 1994 after 828 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K984546: Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TK (1999), 1 descendant of its own
- K113313: Molecular Adsorbent Recirculating (Mars) (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K923046
Methodology: https://510kreport.com/methodology