510(k) · Cleared
ClearedBiologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model 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 Aug 13, 1999 as substantially equivalent to K923046 (Hemocleanse, Inc., 1994) and 1 other predicate after a 234-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Aug 13, 1999
- Review
- 234 days
- Class
- Class II
- Product code
- FLD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923046 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK923046 Biologic DT-1000 MachineHemocleanse, Inc. · 1994
- This deviceK984546 Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit…Hemocleanse, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK113313 Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113313Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923046 | Biologic DT-1000 Machine | Hemocleanse, Inc. | 1994 | — |
| 0 (this device) | K984546 | Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model… | Hemocleanse, Inc. | 1999 | — |
| +1 | K113313 | Molecular Adsorbent Recirculating (Mars) | Gambro Renal Products, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923046 | Biologic DT-1000 MachineSummary page 1…r 21 CFR 876.5870) Device to which Substantial Equivalence is being Claimed: Claiming equivalence to BioLogic-DT-1000 Machine with BioLogic- DT® 1000-TK Treatment Kit (K923046, K953751) Device Description: The BioLogic-DT System is a sorbent regenerated detoxification system consisting of the BioLogic-… | 1994 |
| * | K953751 | Biologic-DT SystemSummary page 1…876.5870) Device to which Substantial Equivalence is being Claimed: Claiming equivalence to BioLogic-DT-1000 Machine with BioLogic- DT® 1000-TK Treatment Kit (K923046, K953751) Device Description: The BioLogic-DT System is a sorbent regenerated detoxification system consisting of the BioLogic-DT Machin… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113313 | Molecular Adsorbent Recirculating (Mars) | 2012 | 0 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K113313 (Gambro Renal Products, Inc., 2012) has gone furthest, with 0 descendants of its own.
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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984546: Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model 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/K984546
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026