510(k) K162219 · PWH Administrations Sets With Neuraxial Connectors
CADD® Infusion Disposables Portfolio with NRFit connectors
| Applicant | Smiths Medical Asd, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jul 20, 2017 |
| Received | Aug 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162219
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2026 | ICU Medical, Inc. CADD Yellow Medication Cassette Reservoir with NRFit connector
US Product Codes: 21-7600-24, 21-7609-24
OUS Product Codes:
21-7609-24
21-7600-24
21-7600-24
21-7600-24
21-7609-24
21-7609-24
21-7600-2 Open, Classified |
LHI | None listed |
| Jan 30, 2023 | Smiths Medical ASD Inc. CADD Administration Set, List Numbers:
a) REF 21-7600-24,
b) REF 21-7609-24,
c) REF 21-7624-24,
d) REF 21-7649-24,
e) REF 21-7600-24JP,
f) REF 21-7609-24JP,
g) REF 21-7624-24JP,
h) REF 21-7649 Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.