510(k) · Cleared
Recalled · Class II · 2014EZ-IO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vidacare Corporation · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 17, 2005 as substantially equivalent to K032885 (Vidacare Corporation, 2004) after a 77-day review. Its family tree reaches back 2 generations to 1998. 9 later devices descend from it. It has been recalled once.
- Decided
- Nov 17, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981853 (1998). 9 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK981853 Bone Injection Gun (B.I.G.) DeviceWaismed, Ltd. · 1998
- 1 generation backK032885 Vidaport Intraosseous Infusion SystemVidacare Corporation · 2004
- This deviceK052408 EZ-IOVidacare Corporation · 2005
- Descendant · cites it directly · 5 of its ownK062940 Bone Injection Gun (B.I.G.)Waismed, Ltd. · 2006
- Descendant · 2 generations on · 3 of its ownK142086 Nio -Intraosseous DeviceWaismed, Ltd. · 2014 · Recalled
- Descendant · cites it directly · 2 of its ownK091140 EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous…Vidacare Corporation · 2009 · Recalled
- Descendant · 3 generations on · 1 of its ownK160805 NIO-PWaismed, Ltd. · 2016 · Recalled
- Descendant · cites it directly · 1 of its ownK101026 Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K062940Bone Injection Gun (B.I.G.)Waismed, Ltd. · 2006 · cites it directly5descendants
- K142086Nio -Intraosseous DeviceWaismed, Ltd. · 2014 · 2 generations on3descendants
- K091140EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IOVidacare Corporation · 2009 · cites it directly2descendants
- K160805NIO-PWaismed, Ltd. · 2016 · 3 generations on1descendant
- K101026Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981853 | Bone Injection Gun (B.I.G.) Device | Waismed, Ltd. | 1998 | — |
| −1 | K032885 | Vidaport Intraosseous Infusion System | Vidacare Corporation | 2004 | — |
| 0 (this device) | K052408 | EZ-IO | Vidacare Corporation | 2005 | — |
| +1 | K062940 | Bone Injection Gun (B.I.G.) | Waismed, Ltd. | 2006 | — |
| +2 | K142086 | Nio -Intraosseous Device | Waismed, Ltd. | 2014 | 1 |
| +1 | K091140 | EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion… | Vidacare Corporation | 2009 | 1 |
| +3 | K160805 | NIO-P | Waismed, Ltd. | 2016 | 1 |
| +1 | K101026 | Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO | Vidacare Corporation | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K032885 | Vidaport Intraosseous Infusion SystemSummary page 1…Hypodermic single lumen needle The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]: VidaPort Intraosseous Infusion System (K032885), manufactured by VidaCare. Description of the device: The EZ-I0 (which looks similar to a cordless drill) consists of a… | 2004 |
What descends from it? (9)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2014 | Class II | Z-2672-2014 | Material/Component Contamination | The voluntary recall is due to the needle set not meeting its specifications. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062940 (Waismed, Ltd., 2006) has gone furthest, with 5 descendants of its own.
- 7 other devices also cite its predicate K032885.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
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-I0 is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052408 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052408: EZ-IO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052408
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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