510(k) K040636 ยท FPA Set, Administration, Intravascular
CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
| Applicant | Smiths Medical MD, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, May 19, 2004 |
| Received | Mar 10, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040636
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2025 | ICU Medical Inc. Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24 Open, Classified |
FPA | None listed |
| Jan 30, 2023 | Smiths Medical ASD Inc. CADD Administration Set, List Numbers:
1) REF 21-7300-24,
2) REF 21-7301-24
3) REF 21-7302-24,
4) REF 21-7321-24,
5) REF 21-7322-24,
6) REF 21-7323-24,
7) REF 21-7324-24,
8) REF 21-7333-24,
9) Open, Classified |
FPA | None listed |
| Mar 30, 2017 | Smiths Medical ASD Inc. CADD Administration Set, 21-7339-24, Rx Only, Sterile EO. Terminated |
FPA | None listed |
| Apr 22, 2016 | Smiths Medical ASD, Inc. CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-733 Terminated |
FPA | None listed |
| Mar 17, 2015 | Smiths Medical ASD, Inc. CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only. Terminated |
FPA | None listed |
| Feb 13, 2008 | Smiths Medical MD, Inc. Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.