510(k) · Cleared
ClearedEZ-Mio Manual Driver
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 2, 2005 as substantially equivalent to K032885 (Vidacare Corporation, 2004) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 1992. 13 later devices descend from it.
- Decided
- Nov 2, 2005
- Review
- 83 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K915409 (1992). 6 ancestors in all, the oldest K913258 (1992). 13 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK915409 Intraosseous Access NeedleCook, Inc. · 1992
- 2 generations backK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
- 1 generation backK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
- This deviceK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
- Descendant · cites it directly · 3 of its ownK080865 FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
- Descendant · cites it directly · 3 of its ownK062956 EZ-Mio, EZ-IO Distal TibiaVidacare Corporation · 2006
- Descendant · 2 generations on · 2 of its ownK100124 Fastx Sternal Intraosseous DevicePyng Medical Corp. · 2010 · Recalled
- Descendant · 2 generations on · 2 of its ownK091140 EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous…Vidacare Corporation · 2009 · Recalled
- Descendant · cites it directly · 1 of its ownK190538 NIO-IWaismed, Ltd. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008 · cites it directly3descendants
- K062956EZ-Mio, EZ-IO Distal TibiaVidacare Corporation · 2006 · cites it directly3descendants
- K100124Fastx Sternal Intraosseous DevicePyng Medical Corp. · 2010 · 2 generations on2descendants
- K091140EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IOVidacare Corporation · 2009 · 2 generations on2descendants
- K190538NIO-IWaismed, Ltd. · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915409 | Intraosseous Access Needle | Cook, Inc. | 1992 | — |
| −2 | K022415 | Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST | Waismed, Ltd. | 2002 | — |
| −1 | K043490 | PD-IO Disposable Intraosseous Infusion Needle | Vidacare Corporation | 2005 | — |
| 0 (this device) | K052195 | EZ-Mio Manual Driver | Vidacare Corporation | 2005 | — |
| +1 | K080865 | FAST1 Intraosseous Infusion System | Pyng Medical Corp. | 2008 | — |
| +1 | K062956 | EZ-Mio, EZ-IO Distal Tibia | Vidacare Corporation | 2006 | — |
| +2 | K100124 | Fastx Sternal Intraosseous Device | Pyng Medical Corp. | 2010 | 1 |
| +2 | K091140 | EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion… | Vidacare Corporation | 2009 | 1 |
| +1 | K190538 | NIO-I | Waismed, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K032885 | Vidaport Intraosseous Infusion SystemSummary page 1…2(a)(3)]: Applicant IDevice I510(k) VidaCare Corporation VidaPort Intraosseous Infusion System,* K032885 Vida~aeCo ration PD-10 Disposable lntraosseous Infusion Needle K043490 Description of the device: The EZ-MI… | 2004 |
| * | K043490 | PD-IO Disposable Intraosseous Infusion NeedleSummary page 1…I510(k) VidaCare Corporation VidaPort Intraosseous Infusion System,* K032885 Vida~aeCo ration PD-10 Disposable lntraosseous Infusion Needle K043490 Description of the device: The EZ-MIOI, Manual Driver consists of a proprietary pentagon shaft permanently attach… | 2005 |
What descends from it? (13)
See all 135 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K080865 (Pyng Medical Corp., 2008) has gone furthest, with 3 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?
For pediatric use:
The PD-IOTM infusion system provides intraosseous access in proximal tibia, as an alternative to IV access during emergencies to pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kg).
For adult use:
The EZ-IOTM Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies to adult patients (22 years of age or older, > 40 kg)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052195 · printed Nov 3, 2026
Cite this page
510(k) Report. “K052195: EZ-Mio Manual Driver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K052195
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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