BD Saf-T-Intima™ Subcutaneous Catheter System
FDA 510(k) clearance K251422 · decided 2025-10-08
Clearance details
- K-number
- K251422
- Device name
- BD Saf-T-Intima™ Subcutaneous Catheter System
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-07
- Decision date
- 2025-10-08
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sandy, UT, 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 |
|---|
| ClearSafe Closed System (K261041) | MedSource Labs, LLC | 2026-07-10 |
| MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter (K260539) | MedSource Labs, LLC | 2026-07-09 |
| Introcan Safety® Deep Access XL IV Catheter (K253235) | B.Braun Medical, Inc. | 2026-05-15 |
| BD Insyte™ IV Catheter (K252137) | Becton Dickinson Infusion Therapy Systems, Inc. | 2026-04-02 |
| Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) (K252513) | Poly Medicure Limited | 2026-04-01 |
| SURFLO Hybria Closed System Safety IV Catheter (K252398) | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-17 |
| Polyshield Safety IV Catheters (K252677) | Poly Medicure Limited | 2025-11-05 |
| BD Nexiva™ Closed IV Catheter System (K243403) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-25 |
| BD Cathena™ Safety IV Catheter (K251155) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-11 |
| BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (K251654) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-06-27 |
| BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (K250682) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-06-03 |
| Ruby Intravascular Catheter (K243105) | Venocare, Inc. | 2025-05-16 |
Recalls involving this device
No recalls on record reference this clearance.