510(k) · Cleared
ClearedEZ-Mio Sternal
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 Jan 26, 2007 as substantially equivalent to K052195 (Vidacare Corporation, 2005) and 1 other predicate after a 59-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Jan 26, 2007
- Review
- 59 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K915409 (1992). 9 ancestors in all, the oldest K883014 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK915409 Intraosseous Access NeedleCook, Inc. · 1992
- 3 generations backK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
- 2 generations backK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
- 1 generation backK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
- This deviceK063567 EZ-Mio SternalVidacare Corporation · 2007
- Descendant · cites it directly · 0 of its ownK120661 The T.a.L.O.N. Intraossous Infusion System by VidacreVidacare Corporation · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K120661The T.a.L.O.N. Intraossous Infusion System by VidacreVidacare Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915409 | Intraosseous Access Needle | Cook, Inc. | 1992 | — |
| −3 | K022415 | Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST | Waismed, Ltd. | 2002 | — |
| −2 | K043490 | PD-IO Disposable Intraosseous Infusion Needle | Vidacare Corporation | 2005 | — |
| −1 | K052195 | EZ-Mio Manual Driver | Vidacare Corporation | 2005 | — |
| 0 (this device) | K063567 | EZ-Mio Sternal | Vidacare Corporation | 2007 | — |
| +1 | K120661 | The T.a.L.O.N. Intraossous Infusion System by Vidacre | Vidacare Corporation | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K052195 | EZ-Mio Manual DriverSummary page 1…807.92(a)(3)]: 51 O('k) Trade or Proprietary or Manufacturer Number zModel Name ________ 1 K052195 1 EZ-MIQ Manual Driver 1 Vidacare Corp. 2 K970380 2 F.A.S.T. 1 Intraosseous 2PN eia… | 2005 |
| * | K970380 | F.a.S.T. 1 Intraosseous Infusion SystemSummary page 1…Manufacturer Number zModel Name ________ 1 K052195 1 EZ-MIQ Manual Driver 1 Vidacare Corp. 2 K970380 2 F.A.S.T. 1 Intraosseous 2PN eia op Infusion System (jpowered) ________… | 1997 |
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 |
|---|---|---|---|
| K120661 | The T.a.L.O.N. Intraossous Infusion System by Vidacre | 2012 | 0 |
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K120661 (Vidacare Corporation, 2012) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K052195.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Sternal IO access is Indicated for adult patients when rapid fluid or
pharmacological resuscitation is required in emergencies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063567: EZ-Mio Sternal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063567
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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