Polywin Safety (14G x 51mm +17 more— 510(k) K252513

Clearance details

Device name as filed

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)

Applicant

Poly Medicure Limited

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2025-08-11

Decision date

2026-04-01

Decision

Substantially Equivalent

Clearance type

Special

Location

Faridabad, IN

• K260432 — Ruby Intravascular Catheter2026-09-02
• K260165 — Unimpregnated Central Venous Catheter2026-08-10
• K261041 — ClearSafe Closed System2026-07-10
• K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

• K252677 — Polyshield Safety IV Catheters2025-11-05
• K232234 — Nouvo Safety Set2024-03-15
• K231401 — Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva2023-09-21
• K230616 — Polyguard and Polyshield Safety IV Catheters2023-05-05
• K220312 — Polyfusion IV Administration Sets2023-04-12

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →