GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING— 510(k) K911459
Substantially EquivalentFresenius USA, Inc.
FDA 510(k) clearance K911459 for GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING, Substantially Equivalent on 1991-07-17. Applicant: Fresenius USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Fresenius USA, Inc.
- Product code
- Code KPO
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Concord, CA, US
Recent devices under product code KPO
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- K974584 — FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
- K973378 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
- K961465 — 2008H ON LINE CLEARANCE MONITOR
Adverse events under product code KPO
product code KPO- Death
- 14
- Malfunction
- 775
- Other
- 20
- Total
- 809
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 K911459
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K911459.
Data sourced from openFDA. This site is unofficial and independent of the FDA.