Gambro Multipurpose System MPS-10
FDA 510(k) K881270 · Gambro, Inc.
510(k) numberK881270
Submission
- Device name
- Gambro Multipurpose System MPS-10
- Applicant
- Gambro, Inc.
Lincolnshire, IL, US - Received
- March 24, 1988
- Decision date
- August 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FII – System, Dialysate Delivery, Sealed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FII
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030470 | Nxstage System OneFII · Traditional | Nxstage Medical, Inc. | 07/07/2003SE |
| K872364 | Hemodialysis (SPS), Model 550, Code 5M1309FII · Traditional | Travenol Laboratories, S.A. | 10/13/1987SE |
| K862716 | Hemofiltration System 10FII · Traditional | Gambro, Inc. | 09/09/1986SE |
| K822386 | Cotral I W/4.5 L/Hr. Ultrafiltrat. CapaFII · Traditional | Hospal Medical Corp. | 10/06/1982SE |
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| K070643 | Phoenix Hemodialysis Delivery System, Version 3.35KDI · Traditional | 11/02/2007SE |
| K032431 | Prisma M60/M100 SetsKDI · Special | 09/15/2003SE |
| K896758 | Gambro Bicarbonate Monitor BCM 10-3FKP · Traditional | 09/28/1990SE |
| K896757 | Gambro AK-10 Dialysis System for High FlowsFKP · Traditional | 08/30/1990SE |
| K902481 | Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberFJI · Traditional | 07/27/1990SE |
| K900918 | Gambro Lundia IC-6H Parallel Plate DialyzerKDI · Traditional | 07/16/1990SE |
| K892523 | Gambro Alwall GFS 11,12,PLUS 12 Hollow Fiber DialyFJI · Traditional | 05/11/1989SE |
| K890112 | Engstrom Eliza + CO2 AnalyzerCCK · Traditional | 03/15/1989SE |
Questions and answers
When was Gambro Multipurpose System MPS-10 cleared by the FDA?
Gambro Multipurpose System MPS-10 (K881270) received a 510(k) decision of Substantially Equivalent on August 24, 1988, 153 days after the submission was received.
What is the product code of K881270?
The FDA product code is FII – System, Dialysate Delivery, Sealed, a Class II (moderate risk) device regulated under 21 CFR 876.5860.