510(k) Report

510(k) · Cleared

Cleared

Molecular Adsorbent Recirculating (Mars)

K113313510(k) TraditionalCleared Dec 14, 2012401-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

Gambro Renal Products, Inc. · FLD Apparatus, Hemoperfusion, Sorbent

Cleared on Dec 14, 2012 as substantially equivalent to K984546 (Hemocleanse, Inc., 1999) and 1 other predicate after a 401-day review. Its family tree reaches back 2 generations to 1994.

Decided
Dec 14, 2012
Review
401 days
Class
Class II
Product code
FLD
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K923046 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor1996: 1 other ancestorK923046 · Biologic DT-1000 Machine · Hemocleanse, Inc. · 1994K984546 · Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TK · Hemocleanse, Inc. · 199919901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K984546 · Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TK · Hemocleanse, Inc. · 1999K923046 · Biologic DT-1000 Machine · Hemocleanse, Inc. · 19940
  1. Root · 2 generations backK923046 Biologic DT-1000 MachineHemocleanse, Inc. · 1994
  2. 1 generation backK984546 Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit…Hemocleanse, Inc. · 1999
  3. This deviceK113313 Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K923046Biologic DT-1000 MachineHemocleanse, Inc.1994—
−1K984546Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model…Hemocleanse, Inc.1999—
0 (this device)K113313Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200510
FIG. 1 — Lineage of K113313, 1994–2012Source: 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), 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
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What was it cleared against? (3)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K984546Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TK
Summary page 1
…of the Device BioLogic-Dt System (BioLogic-DT- 1000 with DT- 1000- ____ ____ ____ ___ TK) 510(k) Number K984546 (cleared on August 13, 1999) Classification Name Sorbent H-emoperfusion System Device Class…
Hemocleanse, Inc.1999—
Kept off the family treeK992166FDA’s K992166 is The Aptus (Automated) Application of the HSV 1/2 Igm Elisa Test System. an…
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Zeus Scientific, Inc.1999—
*K033262Molecular Adsorbent Recirculating System (Mars)
Summary page 2
…Molecular Adsorbent Recirculating System (MARS~) Name of the Device Molecular Adsorbent Recirculating System (MARS%)) 510(k) Number K033262 (cleared on May 27, 2005) Classification Name Sorbent Hemoperfusion System Device Class III Product Co…
Gambro Renal Products2005—

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.

What does this lineage say?

  • The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 13.3 years on median.
  • None of the 4 ancestors has a recall.

How does its category compare?

All FLD devices

FLD Apparatus, Hemoperfusion, Sorbent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

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—

What is it indicated for?

The MARS® 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 and/or ion exchange resins. The MARS® is indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS® treatments in HE patients having a decompensation of chronic liver disease demonstrated a…

Read the full statement (148 words)

The MARS® 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 and/or ion exchange resins.

The MARS® is indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS® treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS® treatments to significantly decrease their hepatic encephalopathy scores by at least 2 grades compared to standard medical therapy (SMT).

Contraindication:

The MARS® is not indicated as a bridge to liver transplant. Safety and efficacy has not been demonstrated for this indication in controlled, randomized clinical trials. The effectiveness of the MARS® device in patients that are sedated could not be established in clinical studies and therefore cannot be predicted in sedated patients.

Indications for use as stated in the FDA summary.

More from Gambro Renal Products, Inc.

13 FDA decisions under this applicant name. See the company

  • K133807Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitGambro Renal Products, Inc. · 20141 recall
  • K131516Prismaflex System 7.10Gambro Renal Products, Inc. · 20144 recalls
  • K130039Revaclear 300 Dialyzer, Revaclear 400 DialyzerGambro Renal Products, Inc. · 20137 recalls
  • K110823PrismaflexGambro Renal Products, Inc. · 20119 recalls
  • K103832Phoenix Hemodialysis Delivery SystemGambro Renal Products, Inc. · 20112 recalls

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
  • 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
  • K971015Ahcs Hemoperfusion SystemAmerican Health Care Systems, Inc. · 1997

https://510kreport.com/device/K113313 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113313: Molecular Adsorbent Recirculating (Mars).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113313

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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