GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
FDA 510(k) clearance K041005 · decided 2004-10-07
Clearance details
- K-number
- K041005
- Device name
- GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
- Applicant
- Gambro Renal Products
- Decision
- Substantially Equivalent
- Date received
- 2004-04-19
- Decision date
- 2004-10-07
- Days to decision
- 171 days
- Clearance type
- Abbreviated
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Seal recall (Z-1227-2026) | VANTIVE US HEALTHCARE LLC | 2026-02-02 |
| Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in provid recall (Z-0081-2023) | Baxter Healthcare Corporation | 2022-10-12 |
| Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouc recall (Z-2201-2014) | Gambro Renal Products, Incorporated | 2014-08-13 |
| Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches recall (Z-2202-2014) | Gambro Renal Products, Incorporated | 2014-08-13 |
| Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lu recall (Z-0695-2007) | Gambro Renal Products, Inc. | 2007-03-31 |
| Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, I recall (Z-0032-2007) | Gambro Renal Products, Inc. | 2006-10-12 |