510(k) K242117 ยท PHC Infusion Safety Management Software
LifeShield Infusion Safety Software Suite
| Applicant | Icu Medical, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Apr 2, 2025 |
| Received | Jul 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242117
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2025 | ICU Medical, Inc. LifeShield Drug Library Management (DLM);
LifeShield Infusion Safety Software Suite v2.2
List Number 17003-02 Open, Classified |
PHC | None listed |
| Dec 19, 2025 | ICU Medical, Inc. LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2
Product No. 17003-02 Open, Classified |
PHC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.