# K113313: Molecular Adsorbent Recirculating (Mars)

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products, Inc.
- Decided: Dec 14, 2012 after 401 days
- Product code: FLD (Apparatus, Hemoperfusion, Sorbent)
- Device class: 2
- Regulation: 21 CFR 876.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923046 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984546: Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TK, Hemocleanse, Inc. (1999) Summary page 1.
- K033262: Molecular Adsorbent Recirculating System (Mars), Gambro Renal Products (2005) Summary page 2.

## Cited in the summary but kept off the family tree
- K992166: The Aptus (Automated) Application of the HSV 1/2 Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for, Zeus Scientific, Inc. (1999). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
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.

Source page: https://510kreport.com/device/K113313
Methodology: https://510kreport.com/methodology