LifeShield Infusion Safety Software Suite— 510(k) K242117
Substantially EquivalentIcu Medical, Inc.
FDA 510(k) clearance K242117 for LifeShield Infusion Safety Software Suite, Substantially Equivalent on 2025-04-02. Applicant: Icu Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Icu Medical, Inc.
- Product code
- Code PHC
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, IL, US
Recent devices under product code PHC
view allMore clearances from Icu Medical, Inc.
view allRecalls naming K242117
K-number listed on FDA's recall record- Z-0965-2026 — LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
- Z-0966-2026 — LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K242117.
Data sourced from openFDA. This site is unofficial and independent of the FDA.