510(k) · Cleared
ClearedBiologic-DT System (Biologic-DT-1000 with DT-1000-TK)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemocleanse, Inc. · FLD Apparatus, Hemoperfusion, Sorbent
Cleared on Sep 10, 1999 after a 72-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 10, 1999
- Review
- 72 days
- Class
- Class II
- Product code
- FLD
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FLD devicesFLD Apparatus, Hemoperfusion, Sorbent: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLD
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FLD
Too few FLD 510(k)s in any year since 2007 to give a median.
Recalls per year · FLD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLD
2in 2022
MAUDE reports naming product code FLD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 4 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 21 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992196: Biologic-DT System (Biologic-DT-1000 with DT-1000-TK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992196
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026