Dose IQ Safety Software
FDA 510(k) clearance K211124 · decided 2022-08-30
Clearance details
- K-number
- K211124
- Device name
- Dose IQ Safety Software
- Applicant
- Baxter Healthcare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-04-15
- Decision date
- 2022-08-30
- Days to decision
- 502 days
- Clearance type
- Traditional
- Product code
- PHC
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Deerfield Lake, IL, US
- Third-party review
- No
- Expedited review
- No
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| LifeShield Infusion Safety Software Suite (K252130) | Icu Medical, Inc. | 2026-04-02 |
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| LifeShield Infusion Safety Software Suite (K242117) | Icu Medical, Inc. | 2025-04-02 |
| Dose IQ Safety Software (K230665) | Baxter Healthcare Corporation | 2024-03-29 |
| LifeShield™ Infusion Safety Software Suite (K223606) | Icu Medical, Inc. | 2023-08-24 |
| 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Preveleak Surgical Sealant (P100030/S021) | Baxter Healthcare Corporation | 2025-07-10 |
| PerClot® Polysaccharide Hemostatic System (P210036/S005) | Baxter Healthcare Corporation | 2025-04-25 |
| Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK (P100030/S020) | Baxter Healthcare Corporation | 2025-04-11 |
| PerClot Polysaccharide Hemostatic System (P210036/S002) | Baxter Healthcare Corporation | 2024-12-20 |
| Seprafilm Adhesion Barrier (P950034/S059) | Baxter Healthcare Corporation | 2024-12-19 |
| PerClot Polysaccharide Hemostatic System (P210036/S004) | Baxter Healthcare Corporation | 2024-07-18 |
| Seprafilm Adhesion Barrier (P950034/S058) | Baxter Healthcare Corporation | 2024-07-03 |
| Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips (P100030/S019) | Baxter Healthcare Corporation | 2024-06-06 |