# Poly Medicure Limited

- Location (FDA's records): Faridabad, IN
- FDA decisions: 7 (2023–2026): 7 510(k) clearances
- Product codes: FOZ (5), FPA (1), LJH (1)
- 510(k) review time since 2016: median 181 days, against 160 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- B.Braun Medical, Inc.: 2 (https://510kreport.com/company/b-braun-medical)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Becton Dickinson Infusion Therapy Systems, Inc.: 1 (https://510kreport.com/company/becton-dickinson-infusion-therapy-systems)

## Its most-cited devices
- K230616: Polyguard and Polyshield Safety IV Catheters (2023), cited by 1
- K231401: Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva (2023), cited by 1

## Recent decisions
- K261670: Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR  Irrigation Set, Y-Type, 2 Leads, Tubing  90 with Luer Lock - Sterile (30032); Polymed  TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed  TUR Irrigation Set, Single Spike, Tubing 80, with Luer Lock - Sterile (30034); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 80, with Luer Lock- Sterile (30035); Polymed  TUR Irrigation Set, Y- Type, 4 Leads (Oct 23, 2026)
- K252513: 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) (Apr 1, 2026)
- K252677: Polyshield Safety IV Catheters (Nov 5, 2025)
- K232234: Nouvo Safety Set (Mar 15, 2024)
- K231401: Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva (Sep 21, 2023)
- K230616: Polyguard and Polyshield Safety IV Catheters (May 5, 2023)
- K220312: Polyfusion IV Administration Sets (Apr 12, 2023)

Source page: https://510kreport.com/company/poly-medicure