510(k) · Cleared
Recalled · Class III · 2017EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-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 Oct 14, 2009 as substantially equivalent to K062956 (Vidacare Corporation, 2006) and 2 other predicates after a 177-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 14, 2009
- Review
- 177 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K915409 (1992). 9 ancestors in all, the oldest K913258 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK915409 Intraosseous Access NeedleCook, Inc. · 1992
- 4 generations backK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
- 3 generations backK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
- 2 generations backK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
- 1 generation backK062956 EZ-Mio, EZ-IO Distal TibiaVidacare Corporation · 2006
- This deviceK091140 EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous…Vidacare Corporation · 2009
- Descendant · cites it directly · 1 of its ownK101026 Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation · 2010
- Descendant · cites it directly · 0 of its ownK132583 EZ-IO Intraosseous Infusion SystemVidacare Corporation · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915409 | Intraosseous Access Needle | Cook, Inc. | 1992 | — |
| −4 | K022415 | Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST | Waismed, Ltd. | 2002 | — |
| −3 | K043490 | PD-IO Disposable Intraosseous Infusion Needle | Vidacare Corporation | 2005 | — |
| −2 | K052195 | EZ-Mio Manual Driver | Vidacare Corporation | 2005 | — |
| −1 | K062956 | EZ-Mio, EZ-IO Distal Tibia | Vidacare Corporation | 2006 | — |
| 0 (this device) | K091140 | EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion… | Vidacare Corporation | 2009 | — |
| +1 | K101026 | Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO | Vidacare Corporation | 2010 | — |
| +1 | K132583 | EZ-IO Intraosseous Infusion System | Vidacare Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K062956 | EZ-Mio, EZ-IO Distal TibiaSummary page 1…ce [807.92(a) (3)]: 510(k) Manufacturer Nm0(k) r 0 Trade or Proprietaryor Model Name :Number 1 1 K062956 1 EZ-MIO, EZ-IO, Distal Tibia 1 Vidacare Corp. 2 K032885 2 Vidaport Intraosseous Infusion System… | 2006 |
| * | K032885 | Vidaport Intraosseous Infusion SystemSummary page 1…Manufacturer Nm0(k) r 0 Trade or Proprietaryor Model Name :Number 1 1 K062956 1 EZ-MIO, EZ-IO, Distal Tibia 1 Vidacare Corp. 2 K032885 2 Vidaport Intraosseous Infusion System 2 Vidacare Corp. 3 K052408 3 EZ-IO, Humeral Head… | 2004 |
| * | K052408 | EZ-IOSummary page 1…1 1 K062956 1 EZ-MIO, EZ-IO, Distal Tibia 1 Vidacare Corp. 2 K032885 2 Vidaport Intraosseous Infusion System 2 Vidacare Corp. 3 K052408 3 EZ-IO, Humeral Head 3 Vidacare Corp. Regulatory Specialists, Inc… | 2005 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2017 | Class III | Z-1829-2017 | Incorrect or no expiration date | Some of the individual unit packaging (pouches) may be missing the lot number an expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K101026 (Vidacare Corporation, 2010) has gone furthest, with 1 descendant 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. 2009, 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?
EZ-MIO and EZ-IO: The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Vidaport Intraosseous Infusion System: The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically…
Read the full statement (119 words)
EZ-MIO and EZ-IO:
The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
Vidaport Intraosseous Infusion System:
The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only.
EZ-IO Humeral Head:
The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, 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/K091140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091140: EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091140
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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