GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS— 510(k) K041005
Substantially EquivalentGambro Renal Products
FDA 510(k) clearance K041005 for GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS, Substantially Equivalent on 2004-10-07. 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
- Abbreviated
- 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 K041005
K-number listed on FDA's recall record- Z-1227-2026 — PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Z-0081-2023 — Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
- Z-2378-2021 — Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
- Z-2201-2014 — Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Z-2202-2014 — Prismaflex M100. Product number 106697. 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 K041005.
Data sourced from openFDA. This site is unofficial and independent of the FDA.