CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
FDA 510(k) clearance K040636 · decided 2004-05-19
Clearance details
- K-number
- K040636
- Device name
- CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
- Applicant
- Smiths Medical MD, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-10
- Decision date
- 2004-05-19
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented st recall (Z-2522-2025) | ICU Medical Inc. | 2025-09-04 |
| CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302 recall (Z-0963-2023) | Smiths Medical ASD Inc. | 2023-01-30 |
| CADD Administration Set, 21-7339-24, Rx Only, Sterile EO. recall (Z-1767-2017) | Smiths Medical ASD Inc. | 2017-03-30 |
| CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx onl recall (Z-1286-2015) | Smiths Medical ASD, Inc. | 2015-03-17 |
| Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 1 recall (Z-0879-2008) | Smiths Medical MD, Inc. | 2008-02-13 |