GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS— 510(k) K042938
Substantially EquivalentGambro Renal Products
FDA 510(k) clearance K042938 for GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS, Substantially Equivalent on 2005-01-06. Applicant: Gambro Renal Products. Device class: 2.
Clearance details
- Applicant
- Gambro Renal Products
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lakewood, CO, US
Recent devices under product code KDI
view allMore clearances from Gambro Renal Products
view allAdverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K042938
K-number listed on FDA's recall record- Z-1229-2026 — PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Z-1230-2026 — PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Z-0083-2023 — Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies.
- Z-0085-2023 — Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
- Z-2379-2021 — Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
- Z-2204-2014 — Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Z-2205-2014 — Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042938.
Data sourced from openFDA. This site is unofficial and independent of the FDA.