ALARIS SAFETY MALE LUER
FDA 510(k) clearance K053049 · decided 2006-01-12
Clearance details
- K-number
- K053049
- Device name
- ALARIS SAFETY MALE LUER
- Applicant
- Cardinal Health, Alaris Products
- Decision
- Substantially Equivalent
- Date received
- 2005-10-28
- Decision date
- 2006-01-12
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- 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 |
|---|---|---|
| Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap B recall (Z-1970-2025) | BD SWITZERLAND SARL | 2025-06-12 |
| BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500 recall (Z-1973-2025) | BD SWITZERLAND SARL | 2025-06-12 |
| Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA. recall (Z-0218-2008) | Cardinal Health 303 Inc DBA Alaris Products | 2007-11-08 |