Cleared Special

BD Insyte? Autoguard? Shielded IV Catheter, BD Insyte? Autoguard? BC Shielded IV Catheter and BD Insyte? Autoguard? BC Pro Shielded IV Catheter

K251654 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital

Jun 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K251654 is an FDA 510(k) clearance for the BD Insyte? Autoguard? Shielded IV Catheter, BD Insyte? Autoguard? BC Shielded IV Catheter and BD Insyte? Autoguard? BC Pro Shielded IV Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on June 27, 2025, 28 days after receiving the submission on May 30, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K251654 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2025
Decision Date	June 27, 2025
Days to Decision	28 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200