GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C— 510(k) K012383
Substantially EquivalentAlaris Medical Systems, Inc.
FDA 510(k) clearance K012383 for GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C, Substantially Equivalent on 2001-10-02. Applicant: Alaris Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Alaris Medical Systems, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Alaris Medical Systems, Inc.
view all- K043299 — MEDLEY PCA MODULE, MODEL 8120
- K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
- K031741 — MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
- K032233 — MEDLEY PCA MODULE, MODEL 8120
- K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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 K012383
K-number listed on FDA's recall record- Z-1360-2020 — CareFusion Alaris Pump Module, Model 8100
- Z-1361-2020 — CareFusion Alaris Syringe Module, Model 8110
- Z-1362-2020 — CareFusion Alaris PCA Module, Model 8120
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012383.
Data sourced from openFDA. This site is unofficial and independent of the FDA.