PRISMA M60/M100 SETS
FDA 510(k) clearance K032431 · decided 2003-09-15
Clearance details
- K-number
- K032431
- Device name
- PRISMA M60/M100 SETS
- Applicant
- Gambro, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-06
- Decision date
- 2003-09-15
- Days to decision
- 40 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic recall (Z-2195-2014) | Gambro Renal Products, Incorporated | 2014-08-13 |
| Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouc recall (Z-2196-2014) | Gambro Renal Products, Incorporated | 2014-08-13 |
| Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 po recall (Z-2197-2014) | Gambro Renal Products, Incorporated | 2014-08-13 |
| Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches recall (Z-2198-2014) | Gambro Renal Products, Incorporated | 2014-08-13 |
| Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plasti recall (Z-2199-2014) | Gambro Renal Products, Incorporated | 2014-08-13 |
| Gambro Prisma M100 preset, Part No. 8353486. recall (Z-0705-06) | Gambro Renal Products, Inc. | 2006-04-05 |