Gambro, Inc.
Lakewood, CO, US
Gambro, Inc. appears in FDA device records in Lakewood, CO. FDA records list 87 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 87
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 87FDA records hold 87 510(k) clearances for Gambro, Inc. between 1976 and 2009. The busiest year on record is 1980, with 14. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 3 |
| 1978 | 2 |
| 1980 | 14 |
| 1981 | 4 |
| 1982 | 11 |
| 1983 | 11 |
| 1984 | 6 |
| 1985 | 5 |
| 1986 | 9 |
| 1987 | 4 |
| 1988 | 5 |
| 1989 | 3 |
| 1990 | 4 |
| 2003 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K083158 | EXALIS, SOFTWARE VERSION 1.15 | KDI | Substantially Equivalent | |
| K072093 | PRISMAFLEX SYSTEM, VERSION 3.20 | KDI | Substantially Equivalent | |
| K070643 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 | KDI | Substantially Equivalent | |
| K032431 | PRISMA M60/M100 SETS | KDI | Substantially Equivalent | |
| K896758 | GAMBRO BICARBONATE MONITOR BCM 10-3 | FKP | Substantially Equivalent | |
| K896757 | GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS | FKP | Substantially Equivalent | |
| K902481 | GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER | FJI | Substantially Equivalent | |
| K900918 | GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER | KDI | Substantially Equivalent | |
| K892523 | GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY | FJI | Substantially Equivalent | |
| K890112 | ENGSTROM ELIZA + CO2 ANALYZER | CCK | Substantially Equivalent | |
| K890111 | GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER | FJI | Substantially Equivalent | |
| K883589 | GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER | FJI | Substantially Equivalent | |
| K881270 | GAMBRO MULTIPURPOSE SYSTEM MPS-10 | FII | Substantially Equivalent | |
| K872482 | GAMBRO-ENGSTROM ERICA IV RESPIRATOR | CBK | Substantially Equivalent | |
| K880084 | GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS | FJI | Substantially Equivalent | |
| K880083 | GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS | FJI | Substantially Equivalent | |
| K873643 | GAMBRO ADSORBA 150C | FLD | Substantially Equivalent | |
| K873155 | GAMBRO BICART SYSTEM | FKP | Substantially Equivalent | |
| K871108 | GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER | KDI | Substantially Equivalent | |
| K864095 | ENGSTROM EDITH MODELS 500,1000,1500 & 1500F | BYD | Substantially Equivalent | |
| K864094 | GAMBRO FLUID CONTROL MONITOR FCM 10-1 | FKP | Substantially Equivalent | |
| K864083 | GAMBRO BICARBONATE MONITOR BCM 10-2 | FKP | Substantially Equivalent | |
| K862840 | GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N | FJG | Substantially Equivalent | |
| K862716 | HEMOFILTRATION SYSTEM 10 | FII | Substantially Equivalent | |
| K860682 | GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET | CGA | Substantially Equivalent | |
| K862025 | ENGSTROM ERICA II RESPIRATOR | CBK | Substantially Equivalent | |
| K860076 | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 | DTW | Substantially Equivalent | |
| K860938 | GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS | KDI | Substantially Equivalent | |
| K853406 | GAMBRO LUNDIA PRO 3 & 5 DIALYZER | FJG | Substantially Equivalent | |
| K854309 | GAMBRO BLOOD CONCENTRATOR SETS 16,60,200 | KDI | Substantially Equivalent | |
| K852455 | GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 | KRI | Substantially Equivalent | |
| K852454 | CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM | FLL | Substantially Equivalent | |
| K850621 | GAMBRO PLASMAFILTRATION SYSTEM | LKN | Substantially Equivalent | |
| K851230 | GAMBRO PRESSURE MONITOR GUARDS | FIB | Substantially Equivalent | |
| K842503 | GAMBRO PULSATILE MONITOR PLM 10-200 | DWA | Substantially Equivalent | |
| K831404 | BLOOD MONITOR BMM 10-4 | LLB | Substantially Equivalent | |
| K840720 | FIBER HEMOFILTERS FH55-FH77 & 88 | KOJ | Substantially Equivalent | |
| K840645 | ENGSTROM ELIZA DUO CO2 & O2 ANALYZ | CCL | Substantially Equivalent | |
| K840543 | BLOOD CONCENTRATOR 140 | KDI | Substantially Equivalent | |
| K831784 | HEMOFILTRATION SYSTEM | KDI | Substantially Equivalent | |
| K832894 | LUNDIA 10-2-L PARALLEL PLATE HEMODIALY | KOC | Substantially Equivalent | |
| K831677 | HYPER-HYPOTHERMIA UNIT HYPO 10-200 | DWC | Substantially Equivalent | |
| K831606 | GF-180-L HOLLOW FIBER HEMODIALYSIS | KOC | Substantially Equivalent | |
| K830673 | CRAFON ARTHROSCOPY LINES | HRX | Substantially Equivalent | |
| K831338 | LUNDIA 10-3-L PARALLEL FLOW DIALYZER | KOC | Substantially Equivalent | |
| K830596 | ULTRAFILTRATION MONITOR UFM-10-2 | KDI | Substantially Equivalent | |
| K830677 | BLOOD LINE SETS FOR HEMOFILTRATION | FJK | Substantially Equivalent | |
| K830905 | LUNDIA 10-2-N PARALLEL FLOW DIALYZER | KOC | Substantially Equivalent | |
| K823848 | CRAFTON ARTHROSCOPY PUMP AP-10 | HRX | Substantially Equivalent | |
| K830284 | FH 101, FH 202 & FH 303 FIBER HEMOFILTER | KDI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- KRIAccessory Equipment, Cardiopulmonary Bypass
- KOJAirbrush
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- FLDApparatus, Hemoperfusion, Sorbent
- HRXArthroscope
- BYDCondenser, Heat And Moisture (Artificial Nose)
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components
- FLLContinuous Measurement Thermometer
- DWAControl, Pump Speed, Cardiopulmonary Bypass
- DWCController, Temperature, Cardiopulmonary Bypass
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- FJGDialyzer, Parallel Flow
- FHSDialyzer, Single Coil
- DTXGas Control Unit, Cardiopulmonary Bypass
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass
- CGAGlucose Oxidase, Glucose
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- FIENeedle, Fistula
- DTZOxygenator, Cardiopulmonary Bypass
- FIBProtector, Transducer, Dialysis
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type
- LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic
- KDJSet, Administration, For Peritoneal Dialysis, Disposable
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FLCStation, Dialysis Control, Negative Pressure Type
- FKRSubsystem, Proportioning
- FIPSubsystem, Water Purification
- LLBSystem, Blood, Extracorporeal And Accessories
- FKQSystem, Dialysate Delivery, Central Multiple Patient
- FIISystem, Dialysate Delivery, Sealed
- KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal
- FILSystem, Dialysate Delivery, Single Pass
- FKPSystem, Dialysate Delivery, Single Patient
- CBKVentilator, Continuous, Facility Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain