Cleared Special

K252677 - Polyshield Safety IV Catheters (FDA 510(k) Clearance)

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

K252677 · Poly Medicure Limited · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 2025
Decision
72d
Days
Class 2
Risk

K252677 is an FDA 510(k) clearance for the Polyshield Safety IV Catheters. 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 November 5, 2025 after a review of 72 days - a notably fast clearance 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. Low regulatory complexity profile. 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 K252677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2025
Decision Date November 05, 2025
Days to Decision 72 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
56d faster than avg
Panel avg: 128d · This submission: 72d
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

Donawa Lifescience
Roger Gray

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 K252677.
BD Insyte™ IV Catheter
K252137 · Becton Dickinson Infusion Therapy Systems, Inc. · Apr 2026
Polywin Safety (14G x 51mm
K252513 · Poly Medicure Limited · Apr 2026
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K252398 · Terumo Medical Products Hangzhou Co., Ltd. · Dec 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