510(k) Report

510(k) · Cleared

Cleared

Biologic-DT System

K953751510(k) TraditionalCleared Feb 15, 1996189-day reviewClass II21 CFR 876.5870

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hemocleanse, Inc. · FLD Apparatus, Hemoperfusion, Sorbent

Cleared on Feb 15, 1996 after a 189-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 15, 1996
Review
189 days
Class
Class II
Product code
FLD
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK953751 Biologic-DT SystemHemocleanse, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK984546 Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit…Hemocleanse, Inc. · 1999
  3. Descendant · 2 generations on · 0 of its ownK113313 Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc. · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K984546Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TKHemocleanse, Inc. · 1999 · cites it directly1descendant
  • K113313Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953751Biologic-DT SystemHemocleanse, Inc.1996—
+1K984546Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model…Hemocleanse, Inc.1999—
+2K113313Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
201210
FIG. 1 — Lineage of K953751, 1996–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K984546Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TKHemocleanse, Inc.19991

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?

  • Of its descendants, K984546 (Hemocleanse, Inc., 1999) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FLD devices

FLD Apparatus, Hemoperfusion, Sorbent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLD

1in 2014

2012: 12014: 1
2007high 1 (2012) · low 0 (2007)2026

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

2007: 42017: 1
2007high 4 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FLD

2in 2022

2010: 12014: 12017: 212018: 92019: 62020: 32021: 62022: 2
2007high 21 (2017) · low 0 (2007)2025

MAUDE reports naming product code FLD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—40
20080—00
20090—00
20100—01
20110—00
20121—00
20130—00
20141—01
20150—00
20160—00
20170—121
20180—09
20190—06
20200—03
20210—06
20220—02
20230—00
20240—00
20250—00
20260—0—

More from Hemocleanse, Inc.

5 FDA decisions under this applicant name. See the company

  • K993330Thermochem-HT SystemHemocleanse, Inc. · 1999
  • K992196Biologic-DT System (Biologic-DT-1000 with DT-1000-TK)Hemocleanse, Inc. · 1999
  • K984546Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TKHemocleanse, Inc. · 1999
  • K923046Biologic DT-1000 MachineHemocleanse, Inc. · 1994

Recent decisions in FLD

The FLD category page

  • K133807Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitGambro Renal Products, Inc. · 20141 recall
  • K113313Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc. · 2012
  • K033262Molecular Adsorbent Recirculating System (Mars)Gambro Renal Products · 2005
  • K992196Biologic-DT System (Biologic-DT-1000 with DT-1000-TK)Hemocleanse, Inc. · 1999
  • K984546Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TKHemocleanse, Inc. · 1999

https://510kreport.com/device/K953751 · printed Nov 5, 2026

Cite this page

510(k) Report. “K953751: Biologic-DT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953751

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026