BD Intelliport System
FDA 510(k) clearance K182092 · decided 2019-04-30
Clearance details
- K-number
- K182092
- Device name
- BD Intelliport System
- Applicant
- Becton, Dickinson and Company
- Decision
- Substantially Equivalent
- Date received
- 2018-08-03
- Decision date
- 2019-04-30
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- PHC
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Franklin Lakes, NJ, 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 (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 |
| 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 |
|---|---|---|
| BD ONCLARITY HPV ASSAY (P160037/S022) | Becton, Dickinson and Company | 2025-08-25 |
| BD Onclarity HPV Assay (P160037/S023) | Becton, Dickinson and Company | 2025-07-02 |
| Onclarity HPV Assay (P160037/S021) | Becton, Dickinson and Company | 2025-03-12 |
| BD Onclarity HPV Assay (P160037/S020) | Becton, Dickinson and Company | 2024-11-05 |
| BD Onclarity HPV Assay (P160037/S017) | Becton, Dickinson and Company | 2024-05-14 |
| BD Onclarity HPV Assay (P160037/S019) | Becton, Dickinson and Company | 2024-04-18 |
| BD Onclarity HPV Assay (P160037/S018) | Becton, Dickinson and Company | 2023-11-20 |
| BD Onclarity HPV (P160037/S016) | Becton, Dickinson and Company | 2023-11-15 |