510(k) · Cleared
ClearedPowered PD-IO 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 Oct 20, 2005 as substantially equivalent to K043490 (Vidacare Corporation, 2005) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1992. 3 later devices descend from it.
- Decided
- Oct 20, 2005
- Review
- 90 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). 3 later devices descend from it, 2 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 deviceK051992 Powered PD-IO Intraosseous Infusion SystemVidacare Corporation · 2005
- Descendant · cites it directly · 2 of its ownK063142 Manual PD-IO; Powered PD-IOVidacare Corporation · 2006
- Descendant · cites it directly · 1 of its ownK101026 Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation · 2010
- Descendant · 2 generations on · 0 of its ownK132583 EZ-IO Intraosseous Infusion SystemVidacare Corporation · 2014
Most influential descendants
Showing 3 of 3 · See all- K063142Manual PD-IO; Powered PD-IOVidacare Corporation · 2006 · cites it directly2descendants
- K101026Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation · 2010 · cites it directly1descendant
- K132583EZ-IO Intraosseous Infusion SystemVidacare Corporation · 2014 · 2 generations on0descendants
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) | K051992 | Powered PD-IO Intraosseous Infusion System | Vidacare Corporation | 2005 | — |
| +1 | K063142 | Manual PD-IO; Powered PD-IO | Vidacare Corporation | 2006 | — |
| +1 | K101026 | Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO | Vidacare Corporation | 2010 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K043490 | PD-IO Disposable Intraosseous Infusion NeedleSummary page 1…Hypodermic single lumen needle The legally marketed devices to which we are claiming equivalence E807.92(a)(3)1: PD-10 Disposable lntraosseous Infusion Needle (K043490), manufactured by VidaCare. VidaPort lntraosseous Infusion System (K032885), manufactured by VidaC are.… | 2005 |
| * | K032885 | Vidaport Intraosseous Infusion SystemSummary page 1…alence E807.92(a)(3)1: PD-10 Disposable lntraosseous Infusion Needle (K043490), manufactured by VidaCare. VidaPort lntraosseous Infusion System (K032885), manufactured by VidaC are. Description of the device: The Powered PD-10 lntraosseous Infusion System (which looks s… | 2004 |
What descends from it? (3)
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)
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, K063142 (Vidacare Corporation, 2006) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K043490.
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 Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051992: Powered PD-IO 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/K051992
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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