K252130
- 510(k) number
- K252130
- Device name
- LifeShield Infusion Safety Software Suite
- Applicant
- Icu Medical, Inc. IL · US
- Product code
- PHC — Infusion Safety Management Software
- Decision date
- 2026-04-02
- Date received
- 2025-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252130.pdf
Official FDA record: K252130
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.