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FDA 510(k)

BD Insyte™ IV Catheter

K-Number: K252137 · 2026-04-02

ApplicantBecton Dickinson Infusion Therapy Systems, Inc.
Decision Date2026-04-02
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Insyte™ IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K252137. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Insyte™ IV Catheter?

BD Insyte™ IV Catheter is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K252137.

When did BD Insyte™ IV Catheter receive FDA 510(k) clearance?

BD Insyte™ IV Catheter received FDA 510(k) clearance on 2026-04-02, under 510(k) number K252137.

Who is the listed applicant for BD Insyte™ IV Catheter?

The FDA 510(k) record lists Becton Dickinson Infusion Therapy Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Insyte™ IV Catheter?

The FDA product code for BD Insyte™ IV Catheter is FOZ.

Other records listing Becton Dickinson Infusion Therapy Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251422BD Saf-T-Intima™ Subcutaneous Catheter SystemK243403BD Nexiva™ Closed IV Catheter SystemK251155BD Cathena™ Safety IV CatheterK251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterK250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConnectorK241586PIVO™ Pro Needle-free Blood Collection Device

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Related Devices (Code: FOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252513Polywin 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)Poly Medicure LimitedK252398SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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