Polyshield Safety IV Catheters
FDA 510(k) K252677 · Poly Medicure Limited
510(k) numberK252677
Submission
- Device name
- Polyshield Safety IV Catheters
- Applicant
- Poly Medicure Limited
Faridabad, IN - Received
- August 25, 2025
- Decision date
- November 5, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
| K243403 | BD Nexiva Closed IV Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 07/25/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | 04/01/2026SE |
| K232234 | Nouvo Safety SetFOZ · Traditional | 03/15/2024SE |
| K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaFOZ · Traditional | 09/21/2023SE |
| K230616 | Polyguard and Polyshield Safety IV CathetersFOZ · Traditional | 05/05/2023SE |
| K220312 | Polyfusion IV Administration SetsFPA · Traditional | 04/12/2023SE |
Questions and answers
When was Polyshield Safety IV Catheters cleared by the FDA?
Polyshield Safety IV Catheters (K252677) received a 510(k) decision of Substantially Equivalent on November 5, 2025, 72 days after the submission was received.
What is the product code of K252677?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.