510(k) · Cleared
ClearedBD Intraosseous Vascular Access System EMS Powered Driver (D001003)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Access Systems · MHC Needle, Interosseous
Cleared on Nov 10, 2022 as substantially equivalent to K203193 (Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd], 2021) after a 28-day review. Its family tree reaches back 3 generations to 2014. 2 of the 4 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 10, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- MHC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K141117 (2014). No later device cites it as a predicate yet. 2 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK141117 EZ-IO Intraosseous Infusion SystemVidacare, LLC · 2014 · Recalled
- 2 generations backK191976 Piper GO-IO Intraosseous Infusion SystemPiper Access, LLC · 2019 · Recalled (Class I)
- 1 generation backK203193 BD Intraosseous Infusion SystemBard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] · 2021 · Recalled (Class I)
- This deviceK223198 BD Intraosseous Vascular Access System EMS Powered Driver (D001003)Bard Access Systems · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K141117 | EZ-IO Intraosseous Infusion System | Vidacare, LLC | 2014 | 3 |
| −2 | K191976 | Piper GO-IO Intraosseous Infusion System | Piper Access, LLC | 2019 | Class I |
| −1 | K203193 | BD Intraosseous Infusion System | Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] | 2021 | Class I |
| 0 (this device) | K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | Bard Access Systems | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHC device
- #1 K203193 BD Intraosseous Infusion Systemscore -9.7 · 2 generations · Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203193 | BD Intraosseous Infusion SystemSummary page 5…MHC Classification Panel: General Hospital 510(k) Status: K203193 (Concurrence date: March 4, 2021) The BD Intraosseous Vascular Access System provides clinicians and emergency pe… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K203193BD Intraosseous Infusion SystemBard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] · 2021 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K191976Piper GO-IO Intraosseous Infusion SystemPiper Access, LLC · 2019 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All MHC devicesMHC Needle, Interosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MHC
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MHC
Too few MHC 510(k)s in any year since 2007 to give a median.
Recalls per year · MHC
No recall names MHC since 2007.
Adverse event reports per year · MHC
7in 2023
MAUDE reports naming product code MHC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BD Intraosseous Vascular Access System provides intraosseous access in the proximal tibia, distal tibia and humeral
head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access
is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223198: BD Intraosseous Vascular Access System EMS Powered Driver (D001003).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223198
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026