Molecular Adsorbent Recirculating(Mars)
FDA 510(k) K113313 · Gambro Renal Products, Inc.
510(k) numberK113313
Submission
- Device name
- Molecular Adsorbent Recirculating(Mars)
- Applicant
- Gambro Renal Products, Inc.
Lakewood, CO, US - Received
- November 9, 2011
- Decision date
- December 14, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FLD – Apparatus, Hemoperfusion, Sorbent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5870
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FLD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133807 | Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitFLD · Traditional | Gambro Renal Products, Inc. | 03/26/2014SE |
| K033262 | Molecular Adsorbent Recirculating System (Mars)FLD · Traditional | Gambro Renal Products | 05/27/2005SE |
| K992196 | Biologic-Dt System (BIOLOGIC-DT-1000 with DT-1000-TK)FLD · Special | Hemocleanse, Inc. | 09/10/1999SE |
| K984546 | Biologic-Dt Machine, Model DT-1000 and Biologic-Dt Treatment Kit, Model DT-1000-TKFLD · Traditional | Hemocleanse, Inc. | 08/13/1999SE |
| K971015 | Ahcs Hemoperfusion SystemFLD · Traditional | American Health Care Systems, Inc. | 10/22/1997SE |
| K953751 | Biologic-Dt SystemFLD · Traditional | Hemocleanse, Inc. | 02/15/1996SE |
| K885017 | Hemosorba CH-500, CH-350 and CH-180FLD · Traditional | Asahi Medical Co., Ltd. | 03/17/1989SE |
| K873643 | Gambro Adsorba 150CFLD · Traditional | Gambro, Inc. | 12/29/1987SE |
| K840532 | Hemoperfusion System TP-400FLD · Traditional | Extracorporeal Medical Specialities, Inc. | 05/30/1984SE |
| K831029 | Hemoperfusion System TP-400FLD · Traditional | Extracorporeal Medical Specialities, Inc. | 08/26/1983SE |
More from Extracorporeal Medical Specialities, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K133807 | Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitFLD · Traditional | 03/26/2014SE |
| K131516 | Prismaflex System 7.10KDI · Traditional | 01/03/2014SE |
| K130039 | Revaclear 300 Dialyzer, Revaclear 400 DialyzerKDI · Traditional | 05/02/2013SE |
| K120333 | Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyKPO · Traditional | 05/25/2012SE |
| K110823 | PrismaflexKDI · Traditional | 06/17/2011SE |
| K103832 | Phoenix Hemodialysis Delivery SystemKDI · Traditional | 05/20/2011SE |
| K100451 | Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin…MPB · Traditional | 12/21/2010SE |
| K100364 | Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520FJK · Traditional | 11/03/2010SE |
| K093608 | Gambro Water Purification Unit, Models Wro 300 and Wro 300 HFIP · Traditional | 07/29/2010SE |
| K080519 | Prismaflex M150 SetKDI · Traditional | 06/13/2008SE |
Questions and answers
When was Molecular Adsorbent Recirculating(Mars) cleared by the FDA?
Molecular Adsorbent Recirculating(Mars) (K113313) received a 510(k) decision of Substantially Equivalent on December 14, 2012, 401 days after the submission was received.
What is the product code of K113313?
The FDA product code is FLD – Apparatus, Hemoperfusion, Sorbent, a Class II (moderate risk) device regulated under 21 CFR 876.5870.