Company ยท US
Gambro Renal Products
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2014. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (0 in 12 months)
30recalls (0 in 12 months)
23recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 41 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 6 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 6 |
| FLD | Apparatus, Hemoperfusion, Sorbent | 5 |
| FIP | Subsystem, Water Purification | 3 |
| MDP | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma | 2 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 2 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 |
| MSF | Hemodialyzer, Re-Use, High Flux | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2014 | K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT Gambro Renal Products, Inc. | FLD |
| Jan 3, 2014 | K131516 | PRISMAFLEX SYSTEM 7.10 Gambro Renal Products, Inc. | KDI |
| May 2, 2013 | K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER Gambro Renal Products, Inc. | KDI |
| Dec 14, 2012 | K113313 | MOLECULAR ADSORBENT RECIRCULATING(MARS) Gambro Renal Products, Inc. | FLD |
| May 25, 2012 | K120333 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY Gambro Renal Products | KPO |
| Jun 17, 2011 | K110823 | PRISMAFLEX Gambro Renal Products, Inc. | KDI |
| May 20, 2011 | K103832 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM Gambro Renal Products, Inc. | KDI |
| Dec 21, 2010 | K100451 | GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 Gambro Renal Products, Inc. | MPB |
| Nov 3, 2010 | K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 Gambro Renal Products, Inc. | FJK |
| Jul 29, 2010 | K093608 | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H Gambro Renal Products, Inc. | FIP |
| Jun 13, 2008 | K080519 | PRISMAFLEX M150 SET Gambro Renal Products, Inc. | KDI |
| Feb 4, 2008 | K072908 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY Gambro Renal Products | KPO |
| Oct 12, 2007 | K070414 | GAMBRO CARTRIDGE BLOOD SETS Gambro Renal Products | FJK |
| Sep 7, 2007 | K072232 | GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL Gambro Renal Products, Inc. | KDI |
| Feb 15, 2007 | K063183 | PRISMA M10 PRE SET Gambro Renal Products, Inc. | KDI |
| Jan 30, 2007 | K063290 | GAMBRO QUICKSET BLOODLINES Gambro Renal Products | FJK |
| Oct 18, 2006 | K062090 | PRISMA SYSTEM R03.10A Gambro Renal Products | KDI |
| Apr 24, 2006 | K060195 | GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE Gambro Renal Products | KDI |
| Dec 9, 2005 | K051520 | GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H Gambro Renal Products | KDI |
| Nov 2, 2005 | K052253 | MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS Gambro Renal Products | KPO |
| May 27, 2005 | K043342 | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR Gambro Renal Products | FJI |
| May 27, 2005 | K033262 | MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) Gambro Renal Products | FLD |
| Mar 9, 2005 | K042797 | WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Gambro Renal Products | FIP |
| Jan 6, 2005 | K042938 | GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS Gambro Renal Products | KDI |
| Nov 1, 2004 | K040301 | GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A Gambro Renal Products | MPB |
| Oct 7, 2004 | K041005 | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS Gambro Renal Products | KDI |
| May 24, 2004 | K040255 | POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE Gambro Renal Products, Inc. | KDI |
| May 6, 2003 | K023615 | GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR Gambro Renal Products | MSF |
| Aug 6, 2002 | K010805 | PRISMA SYSTEM Gambro Renal Products | KDI |
| Jan 15, 2002 | K013448 | PRISMASATE Gambro Renal Products | KPO |
| Jan 8, 2002 | K013724 | BICART Gambro Renal Products | KPO |
| Nov 1, 2001 | K003957 | DIACLEAR ULTRAFILTER Gambro Renal Products | FIP |
| Oct 31, 2001 | K011221 | PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET Gambro Renal Products | KDI |
| Oct 10, 2001 | K010985 | GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L Gambro Renal Products | KDI |
| Aug 2, 2001 | K011368 | DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS Gambro Renal Products | KPO |
| Jun 4, 2001 | K010667 | GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R Gambro Renal Products | KDI |
| Jul 7, 2000 | K001156 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET Gambro Renal Products | KDI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2014 | Gambro Renal Products Inc Polyflux Revaclear Max Dialyzer, Model Number 110634.
The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure Terminated |
KDI | None listed |
| Dec 1, 2014 | Gambro Renal Products Inc Polyflux Revaclear Dialyzer, Model Number 110633.
The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by h Terminated |
KDI | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541 Terminated |
FLD | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch Terminated |
FLD | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K042938 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K042938 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K080519 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K041005 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K041005 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K011221 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K032431 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K032431 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K032431 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K032431 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K032431 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
MDP | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
MDP | None listed |
| May 21, 2014 | Gambro Renal Products, Incorporated Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634;
Gambro Renal Products, Inc.
Intended for the treatment of acute and chronic renal failure by hemodialysis. Terminated |
KDI | K060195 |
| May 21, 2014 | Gambro Renal Products, Incorporated Polyflux Revaclear, Capillary Dialyzer, Model Number 110633;
Gambro Renal Products, Inc.
Intended for the treatment of acute and chronic renal failure by hemodialysis. Terminated |
KDI | K072232 |
| Apr 11, 2014 | Gambro Renal Products, Incorporated Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gam Terminated |
FJK | None listed |
| Apr 6, 2011 | Gambro Renal Products, Incorporated Prismaflex System, Catalog Number 107493,
Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Terminated |
KDI | K072093 |
| Sep 26, 2008 | Gambro Renal Products, Inc. Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems. Terminated |
FJK | K070414 |
| Sep 26, 2008 | Gambro Renal Products, Inc. Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems. Terminated |
FJK | K070414 |
| Mar 25, 2008 | Gambro Renal Products, Inc. Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401 Terminated |
KDI | K001156 |
| Mar 31, 2007 | Gambro Renal Products, Inc. Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden. Terminated |
KDI | K041005 |
| Nov 21, 2006 | Gambro Renal Products, Inc. Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy. Terminated |
KDI | K001156 |
| Oct 12, 2006 | Gambro Renal Products, Inc. Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy. Terminated |
KDI | K041005 |
| Apr 5, 2006 | Gambro Renal Products, Inc. Gambro Prisma HF1000 preset, Part No. 8399050. Terminated |
KDI | K011221 |
| Apr 5, 2006 | Gambro Renal Products, Inc. Gambro Prisma M100 preset, Part No. 8353486. Terminated |
KDI | K032431 K980386 +1 |
| Oct 1, 2005 | Gambro Renal Products Prisma continuous renal replacement system. Terminated |
KDI | K010805 K993064 |