Cleared Traditional

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva (K231401) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231401 · Poly Medicure Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
129d
Days
Class 2
Risk

K231401 is an FDA 510(k) clearance for the Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva. 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 September 21, 2023 after a review of 129 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Poly Medicure Limited devices

Submission Details

510(k) Number K231401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2023
Decision Date September 21, 2023
Days to Decision 129 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 129d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 132
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K231401.
Nouvo Safety Set
K232234 · Poly Medicure Limited · Mar 2024
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
K233529 · Becton Dickinson Infusion Therapy Systems, Inc. · Dec 2023
Nexiva™ Closed IV Catheter System with NearPort™ IV Access
K231239 · Becton Dickinson Infusion Therapy Systems, Inc. · Sep 2023
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
K223788 · Medsource International, LLC · Sep 2023
OSPREY Closed IV Catheter System (OspreyV2)
K231626 · Skydance Vascular, Inc. · Aug 2023
Mais Central Venous Catheter
K221827 · Saudi Mais Co. For Medical Products · Jun 2023