510(k) · Cleared
ClearedEZ-IO Intraosseous Vascular Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 9, 2018 as substantially equivalent to K141117 (Vidacare, LLC, 2014) after a 269-day review. Its family tree reaches back 1 generation to 2014. 3 later devices descend from it.
- Decided
- Nov 9, 2018
- Review
- 269 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K141117 (2014). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK141117 EZ-IO Intraosseous Infusion SystemVidacare, LLC · 2014 · Recalled
- This deviceK180395 EZ-IO Intraosseous Vascular Access SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2018
- Descendant · cites it directly · 1 of its ownK202492 EZ-IO Intraosseous Vascular Access SystemTeleflex Medical · 2021
- Descendant · 2 generations on · 0 of its ownK231924 EZ-IO Intraosseous Vascular Access SystemTeleflex Medical · 2023
- Descendant · cites it directly · 0 of its ownK220890 IO Needle Safety SheathActuated Medical, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K141117 | EZ-IO Intraosseous Infusion System | Vidacare, LLC | 2014 | 3 |
| 0 (this device) | K180395 | EZ-IO Intraosseous Vascular Access System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2018 | — |
| +1 | K202492 | EZ-IO Intraosseous Vascular Access System | Teleflex Medical | 2021 | — |
| +2 | K231924 | EZ-IO Intraosseous Vascular Access System | Teleflex Medical | 2023 | — |
| +1 | K220890 | IO Needle Safety Sheath | Actuated Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
Planning a device in FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K141117 | EZ-IO Intraosseous Infusion SystemSummary page 4…assification Name: Needle, Hypodermic, Single Lumen (Class II, FMI, 21 CFR 880. 5570) 3. Predicate Device EZ-IO Intraosseous Infusion System (K141117) 4. Device Description The EZ-IO System previously cleared with K141117 is designed to allow the user to insert a needle s… | 2014 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Insertion sites:
ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia
PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal tibia, distal femur
Use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established. Insertion sites:
ADULTS (≥22 years): proximal humerus, proximal tibia, distal tibia
PEDIATRICS (≥12 years through 21 years old): proximal humerus, proximal tibia, distal tibia, distal femur
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180395 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180395: EZ-IO Intraosseous Vascular Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180395
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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