510(k) · Cleared
Recalled · Class II · 2017Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products, Inc. · FLD Apparatus, Hemoperfusion, Sorbent
Cleared on Mar 26, 2014 after a 100-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Mar 26, 2014
- Review
- 100 days
- Class
- Class II
- Product code
- FLD
- Recalls
- 1
- 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2017 | Class II | Z-0411-2018 | Nonconforming Material/Component | Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment… |
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. 2014, this device’s year, is highlighted.
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?
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 de-compensation 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 (234 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 de-compensation 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 hats 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.
The Prismaflex control unit is intended for:
* Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
* Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
* Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more.
All treatments administered via the Prismaflex control unit must be prescribed by a physician.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K133807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133807: Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133807
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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