510(k) · Cleared
Recalled · Class II · 2019EZ-IO Intraosseous Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vidacare, LLC · FMI Needle, Hypodermic, Single Lumen
Cleared on Jul 8, 2014 after a 69-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 of the 10 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 8, 2014
- Review
- 69 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 3
- Predicates
- 1
9 later devices descend from it, 3 citing it directly. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- This deviceK141117 EZ-IO Intraosseous Infusion SystemVidacare, LLC · 2014
- Descendant · cites it directly · 3 of its ownK180395 EZ-IO Intraosseous Vascular Access SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2018
- Descendant · cites it directly · 2 of its ownK191976 Piper GO-IO Intraosseous Infusion SystemPiper Access, LLC · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK202492 EZ-IO Intraosseous Vascular Access SystemTeleflex Medical · 2021
- Descendant · 2 generations on · 1 of its ownK203193 BD Intraosseous Infusion SystemBard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] · 2021 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK191488 SAM IO Intraosseous Access SystemSam® Medical Products, Inc. · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K180395EZ-IO Intraosseous Vascular Access SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2018 · cites it directly3descendants
- K191976Piper GO-IO Intraosseous Infusion SystemPiper Access, LLC · 2019 · cites it directly2descendants
- K202492EZ-IO Intraosseous Vascular Access SystemTeleflex Medical · 2021 · 2 generations on1descendant
- K203193BD Intraosseous Infusion SystemBard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] · 2021 · 2 generations on1descendant
- K191488SAM IO Intraosseous Access SystemSam® Medical Products, Inc. · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K141117 | EZ-IO Intraosseous Infusion System | Vidacare, LLC | 2014 | — |
| +1 | K180395 | EZ-IO Intraosseous Vascular Access System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2018 | — |
| +1 | K191976 | Piper GO-IO Intraosseous Infusion System | Piper Access, LLC | 2019 | Class I |
| +2 | K202492 | EZ-IO Intraosseous Vascular Access System | Teleflex Medical | 2021 | — |
| +2 | K203193 | BD Intraosseous Infusion System | Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] | 2021 | Class I |
| +1 | K191488 | SAM IO Intraosseous Access System | Sam® Medical Products, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 1 |
| 2021 | 2 | 1 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K132638 | FDA’s K132638 is Dimension Creatinine (CRE2) Flex Reagent Cartridge Our reading of the summary gave K132638, FDA’s number for Dimension Creatinine (CRE2) Flex Reagent Cartridge (Siemens Healthcare Diagnostics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “EZ-IO Intraosseous Infusion System”. Kept off the family tree. Summary page 2…s the addition of the distal fe'mur as an insertion site for the pediatric population utilizing the same insertion techniqu~e and devices previously cleared via 510(k) K132638, which includes the insertion sites of the proximal tibia, distal tibia and proximal humerus. Proposed Expanded Indication Dis… | 2014 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 8, 2019 | Class II | Z-0688-2020 | Package design/selection | The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the… |
| Oct 8, 2019 | Class II | Z-0689-2020 | Package design/selection | The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the… |
| Oct 8, 2019 | Class II | Z-0690-2020 | Package design/selection | The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the… |
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 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K203193BD Intraosseous Infusion SystemBard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K180395 (Arrow International, Inc. (Subsidiary of Teleflex, Inc.), 2018) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The EZ-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults 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/K141117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141117: EZ-IO 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/K141117
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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