Cleared Special

K252513 - Polywin Safety (14G x 51mm (FDA 510(k) Clearance)

Also includes:
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)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252513 · Poly Medicure Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
233d
Days
Class 2
Risk

K252513 is an FDA 510(k) clearance for the Polywin Safety (14G x 51mm. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Poly Medicure Limited (Faridabad, IN). The FDA issued a Cleared decision on April 1, 2026 after a review of 233 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Poly Medicure Limited devices

Submission Details

510(k) Number K252513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2025
Decision Date April 01, 2026
Days to Decision 233 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 128d · This submission: 233d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Gsa2 Group, LLC
Sunita Teekasingh

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 502
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K252513.
BD Insyte™ IV Catheter
K252137 · Becton Dickinson Infusion Therapy Systems, Inc. · Apr 2026
SURFLO Hybria Closed System Safety IV Catheter
K252398 · Terumo Medical Products Hangzhou Co., Ltd. · Dec 2025
Polyshield Safety IV Catheters
K252677 · Poly Medicure Limited · Nov 2025
BD Saf-T-Intima™ Subcutaneous Catheter System
K251422 · Becton Dickinson Infusion Therapy Systems, Inc. · Oct 2025
BD Nexiva™ Closed IV Catheter System
K243403 · Becton Dickinson Infusion Therapy Systems, Inc. · Jul 2025
BD Cathena™ Safety IV Catheter
K251155 · Becton Dickinson Infusion Therapy Systems, Inc. · Jul 2025