PRISMA M60/M100 SETS— 510(k) K032431
Substantially EquivalentGambro, Inc.
FDA 510(k) clearance K032431 for PRISMA M60/M100 SETS, Substantially Equivalent on 2003-09-15. Applicant: Gambro, Inc.. Device class: 2.
Clearance details
- Applicant
- Gambro, Inc.
- 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, Inc.
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 K032431
K-number listed on FDA's recall record- Z-2195-2014 — Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Z-2196-2014 — Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Z-2197-2014 — Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Z-2198-2014 — Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Z-2199-2014 — Prisma M100 PRE pump infusion set. Product number 107791. 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 K032431.
Data sourced from openFDA. This site is unofficial and independent of the FDA.