Skip to content

BD Intraosseous Infusion System

by Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]

510(k) K203193

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

Recall on shared 510(k) K203193; other models may be affected

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203193 Date4 Mar 2021ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2872-2026 FDA Class I initiated 30 Jul 2026 on shared 510(k) K203193

    After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy

    • Ongoing Z-1397-2022 FDA Class I initiated 20 Jun 2022 on shared 510(k) K203193

    BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MHC
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BD Intraosseous Infusion System is a needle designed for interosseous infusion, a method of administering fluids and medications directly into the bone marrow cavity when traditional intravenous access is not feasible. It is classified as a Class 2 medical device under the General Hospital category and is intended for use in emergency settings where rapid vascular access is critical.

This system is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K203193) via the Traditional pathway. It is intended for use in clinical environments where intraosseous access is required, such as pediatric or trauma resuscitation, and must be handled in accordance with sterile procedures. The device is available in multiple sizes and configurations, as indicated by the registration numbers (e.g., 3002808227, 3006260740) and is approved for use in MRI environments where specified.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BD Intraosseous Infusion System used for?

    The BD Intraosseous Infusion System is a needle designed for administering fluids and medications directly into the bone marrow cavity when traditional intravenous access is not feasible, particularly in emergency settings like pediatric or trauma resuscitation.

  • Is the BD Intraosseous Infusion System reusable or single-use?

    The BD Intraosseous Infusion System is supplied as a sterile, single-use device and must be handled in accordance with sterile procedures to ensure patient safety and device effectiveness.

  • What sizes and configurations are available for the BD Intraosseous Infusion System?

    The device is available in multiple sizes and configurations, as indicated by the registration numbers such as 3002808227, 3006260740, and others, allowing for flexibility in clinical applications.

  • Can the BD Intraosseous Infusion System be used in MRI environments?

    Yes, the BD Intraosseous Infusion System is approved for use in MRI environments where specified, making it suitable for use in settings where magnetic resonance imaging is required.

  • What is the regulatory status of the BD Intraosseous Infusion System?

    The BD Intraosseous Infusion System is classified as a Class 2 medical device under the General Hospital category and is regulated under FDA 510(k) clearance (K203193) via the Traditional pathway.