Cleared Special

K223198 - BD Intraosseous Vascular Access System EMS Powered Driver (D001003) (FDA 510(k) Clearance)

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

K223198 · Bard Access Systems · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 2022
Decision
28d
Days
Class 2
Risk

K223198 is an FDA 510(k) clearance for the BD Intraosseous Vascular Access System EMS Powered Driver (D001003). Classified as Needle, Interosseous (product code MHC), Class II - Special Controls.

Submitted by Bard Access Systems (Salt Lake Ciy,, US). The FDA issued a Cleared decision on November 10, 2022 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Bard Access Systems devices

Submission Details

510(k) Number K223198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2022
Decision Date November 10, 2022
Days to Decision 28 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
100d faster than avg
Panel avg: 128d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MHC Needle, Interosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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.