510(k) · Cleared
Recalled · Class I · 2026BD Intraosseous Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] · MHC Needle, Interosseous
Cleared on Mar 4, 2021 as substantially equivalent to K191976 (Piper Access, LLC, 2019) after a 127-day review. Its family tree reaches back 2 generations to 2014. 2 of the 4 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Mar 4, 2021
- Review
- 127 days
- Class
- Class II
- Product code
- MHC
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K141117 (2014). 1 later device descends from it, 1 citing it directly. 2 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK141117 EZ-IO Intraosseous Infusion SystemVidacare, LLC · 2014 · Recalled
- 1 generation backK191976 Piper GO-IO Intraosseous Infusion SystemPiper Access, LLC · 2019 · Recalled (Class I)
- This deviceK203193 BD Intraosseous Infusion SystemBard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] · 2021
- Descendant · cites it directly · 0 of its ownK223198 BD Intraosseous Vascular Access System EMS Powered Driver (D001003)Bard Access Systems · 2022
Class I recalls in this family
- K191976 Piper GO-IO Intraosseous Infusion Systemdirect predicate · 2019
Most influential descendants
Showing 1 of 1 · See all- K223198BD Intraosseous Vascular Access System EMS Powered Driver (D001003)Bard Access Systems · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K141117 | EZ-IO Intraosseous Infusion System | Vidacare, LLC | 2014 | 3 |
| −1 | K191976 | Piper GO-IO Intraosseous Infusion System | Piper Access, LLC | 2019 | Class I |
| 0 (this device) | K203193 | BD Intraosseous Infusion System | Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] | 2021 | — |
| +1 | K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | Bard Access Systems | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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 K223198 BD Intraosseous Vascular Access System EMS…score 4.9 · 3 generations · no 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 |
|---|---|---|---|
| * | K191976 | Piper GO-IO Intraosseous Infusion SystemSummary page 4…FMI Predicate Device Regulation Number: 21 CFR 880.5570 Premarket Notification #: K191976 Manufacturer: Piper Access, LLC Classification Panel:… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | 2022 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2026 | Class I | Z-2872-2026 | Component change control | 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… |
| Jun 20, 2022 | Class I | Z-1397-2022 | Process change control | 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… |
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.
- K191976Piper GO-IO Intraosseous Infusion SystemPiper Access, LLC · 2019 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K223198 (Bard Access Systems, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MHC devicesMHC Needle, Interosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Inttaosseous Infusion 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/K203193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203193: BD Intraosseous Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203193
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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