ALARIS SYSTEM WITH MMS, MODEL 8XXX— 510(k) K072105
Substantially EquivalentCardinal Health 303,Inc.
FDA 510(k) clearance K072105 for ALARIS SYSTEM WITH MMS, MODEL 8XXX, Substantially Equivalent on 2007-12-28. Applicant: Cardinal Health 303,Inc.. Device class: 2.
Clearance details
- Applicant
- Cardinal Health 303,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
- Special
- Location
- San Diego, CA, US
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More clearances from Cardinal Health 303,Inc.
view allAdverse 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 K072105
K-number listed on FDA's recall record- Z-1645-2026 — BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- Z-0184-2024 — BD Alaris PCU REF 8015
- Z-0185-2024 — BD Alaris Syringe Module, REF 8110
- Z-0186-2024 — Alaris PCA Module 8120
- Z-1192-2023 — Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072105.
Data sourced from openFDA. This site is unofficial and independent of the FDA.