510(k) · Cleared
ClearedVidaport Intraosseous Infusion System
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 Mar 10, 2004 as substantially equivalent to K981853 (Waismed, Ltd., 1998) after a 176-day review. Its family tree reaches back 1 generation to 1998. 38 later devices descend from it.
- Decided
- Mar 10, 2004
- Review
- 176 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981853 (1998). 38 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK981853 Bone Injection Gun (B.I.G.) DeviceWaismed, Ltd. · 1998
- This deviceK032885 Vidaport Intraosseous Infusion SystemVidacare Corporation · 2004
- Descendant · cites it directly · 16 of its ownK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
- Descendant · cites it directly · 14 of its ownK062833 Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006
- Descendant · cites it directly · 13 of its ownK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
- Descendant · cites it directly · 9 of its ownK052408 EZ-IOVidacare Corporation · 2005 · Recalled
- Descendant · 2 generations on · 7 of its ownK072045 Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 2007
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K043490PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005 · cites it directly16descendants
- K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006 · cites it directly14descendants
- K052195EZ-Mio Manual DriverVidacare Corporation · 2005 · cites it directly13descendants
- K052408EZ-IOVidacare Corporation · 2005 · cites it directly9descendants
- K072045Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 2007 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981853 | Bone Injection Gun (B.I.G.) Device | Waismed, Ltd. | 1998 | — |
| 0 (this device) | K032885 | Vidaport Intraosseous Infusion System | Vidacare Corporation | 2004 | — |
| +1 | K043490 | PD-IO Disposable Intraosseous Infusion Needle | Vidacare Corporation | 2005 | — |
| +1 | K062833 | Powered EZ-IO Bone Marrow Aspiration System | Vidacare Corporation | 2006 | — |
| +1 | K052195 | EZ-Mio Manual Driver | Vidacare Corporation | 2005 | — |
| +1 | K052408 | EZ-IO | Vidacare Corporation | 2005 | 1 |
| +2 | K072045 | Oncontrol Bone Marrow Biopsy System | Vidacare Corporation | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K981853 | Bone Injection Gun (B.I.G.) DeviceSummary page 1…ection system Classification name: Hypodermic single lumen needle The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: K981853, BonE~Injection Gun, manufactured by Wais~ed Ltd. Description of the dev ce: The VidaPort (which looks similar to a cordl… | 1998 |
What descends from it? (38)
See all 388 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043490 | PD-IO Disposable Intraosseous Infusion Needle | 2005 | 16 |
| K062833 | Powered EZ-IO Bone Marrow Aspiration System | 2006 | 14 |
| K052195 | EZ-Mio Manual Driver | 2005 | 13 |
| K052408 | EZ-IO | 2005 | 9 |
| K070759 | Powered EZ-IO Pediatric Bone Marrow Aspiration System | 2007 | 3 |
| K062956 | EZ-Mio, EZ-IO Distal Tibia | 2006 | 3 |
| K051992 | Powered PD-IO Intraosseous Infusion System | 2005 | 3 |
| K091140 | EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IO | 2009 | 2 |
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?
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 VidaPort provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032885: Vidaport 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/K032885
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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