MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
FDA 510(k) clearance K023264 · decided 2002-12-19
Clearance details
- K-number
- K023264
- Device name
- MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
- Applicant
- Alaris Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-30
- Decision date
- 2002-12-19
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Alaris" System with Guardrails" Suite MX with Point of Care Unit recall (Z-1645-2026) | CareFusion 303, Inc. | 2026-03-26 |
| Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Hou recall (Z-2362-2015) | CareFusion 303, Inc. | 2015-08-14 |
| Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Al recall (Z-1794-2009) | Cardinal Health 303 dba Cardinal Health | 2009-08-03 |
| Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built recall (Z-1711-2008) | Cardinal Health 303 Inc DBA Alaris Products | 2008-06-10 |
| U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System recall (Z-1712-2008) | Cardinal Health 303 Inc DBA Alaris Products | 2008-06-10 |