ALARIS SYSTEM WITH MMS, MODEL 8XXX
FDA 510(k) clearance K072105 · decided 2007-12-28
Clearance details
- K-number
- K072105
- Device name
- ALARIS SYSTEM WITH MMS, MODEL 8XXX
- Applicant
- Cardinal Health 303,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-31
- Decision date
- 2007-12-28
- Days to decision
- 150 days
- Clearance type
- Special
- 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 |
| BD Alaris PCU REF 8015 recall (Z-0184-2024) | CareFusion 303, Inc. | 2023-11-07 |
| BD Alaris Syringe Module, REF 8110 recall (Z-0185-2024) | CareFusion 303, Inc. | 2023-11-07 |
| Alaris PCA Module 8120 recall (Z-0186-2024) | CareFusion 303, Inc. | 2023-11-07 |
| Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP a recall (Z-1192-2023) | CareFusion 303, Inc. | 2023-03-01 |