GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
FDA 510(k) clearance K042938 · decided 2005-01-06
Clearance details
- K-number
- K042938
- Device name
- GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
- Applicant
- Gambro Renal Products
- Decision
- Substantially Equivalent
- Date received
- 2004-10-25
- Decision date
- 2005-01-06
- Days to decision
- 73 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
+ Add to Predicate Builder ◉ Watch Gambro Renal Products
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
|---|---|---|
| PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Se recall (Z-1229-2026) | VANTIVE US HEALTHCARE LLC | 2026-02-02 |
| PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Se recall (Z-1230-2026) | VANTIVE US HEALTHCARE LLC | 2026-02-02 |
| Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in recall (Z-0083-2023) | Baxter Healthcare Corporation | 2022-10-12 |
| Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid managemen recall (Z-0085-2023) | Baxter Healthcare Corporation | 2022-10-12 |
| Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouc recall (Z-2204-2014) | Gambro Renal Products, Incorporated | 2014-08-13 |
| Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouc recall (Z-2205-2014) | Gambro Renal Products, Incorporated | 2014-08-13 |