LifeShield Infusion Safety Software Suite
FDA 510(k) clearance K242117 · decided 2025-04-02
Clearance details
- K-number
- K242117
- Device name
- LifeShield Infusion Safety Software Suite
- Applicant
- Icu Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-19
- Decision date
- 2025-04-02
- Days to decision
- 257 days
- Clearance type
- Traditional
- Product code
- PHC
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Forest, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LifeShield Infusion Safety Software Suite (K252130) | Icu Medical, Inc. | 2026-04-02 |
| BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) (K243062) | Becton Dickinson | 2025-06-20 |
| Dose IQ Safety Software (K230665) | Baxter Healthcare Corporation | 2024-03-29 |
| LifeShield™ Infusion Safety Software Suite (K223606) | Icu Medical, Inc. | 2023-08-24 |
| Dose IQ Safety Software (K211124) | Baxter Healthcare Corporation | 2022-08-30 |
| Vigilant Software Suite – Vigilant Master Med (K210075) | Fresenius Kabi AG | 2022-03-01 |
| BD Intelliport System (K182092) | Becton, Dickinson and Company | 2019-04-30 |
| BECTON DICKINSON INTELLIPORT SYSTEM (K141474) | Becton, Dickinson & CO | 2014-12-18 |
| MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 (K141193) | Smiths Medical Asd, Inc. | 2014-07-25 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 L recall (Z-0965-2026) | ICU Medical, Inc. | 2025-12-19 |
| LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 P recall (Z-0966-2026) | ICU Medical, Inc. | 2025-12-19 |