MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110— 510(k) K023264
Substantially EquivalentAlaris Medical Systems, Inc.
FDA 510(k) clearance K023264 for MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110, Substantially Equivalent on 2002-12-19. 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 K023264
K-number listed on FDA's recall record- Z-1645-2026 — BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- Z-0322-2018 — Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The modules are indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous, subcutaneous or epidural. The Alaris Syringe pump and PCA modules can be connected to the Alaris PC unit which is the central programming, monitoring, and power supply component for the Alaris System. The syringe pump and PCA pump uses standard, plastic piston syringes and single-use administration sets with luer-lock connectors.
- Z-2879-2016 — Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.
- Z-2362-2015 — Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023264.
Data sourced from openFDA. This site is unofficial and independent of the FDA.