510(k) · Cleared
ClearedPowered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-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 Jul 27, 2010 as substantially equivalent to K051992 (Vidacare Corporation, 2005) and 3 other predicates after a 105-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Jul 27, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K915409 (1992). 12 ancestors in all, the oldest K913258 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK915409 Intraosseous Access NeedleCook, Inc. · 1992
- 5 generations backK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
- 4 generations backK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
- 3 generations backK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
- 2 generations backK062956 EZ-Mio, EZ-IO Distal TibiaVidacare Corporation · 2006
- 1 generation backK091140 EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous…Vidacare Corporation · 2009 · Recalled
- This deviceK101026 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 1 of 1 · See all- K132583EZ-IO Intraosseous Infusion SystemVidacare Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915409 | Intraosseous Access Needle | Cook, Inc. | 1992 | — |
| −5 | K022415 | Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST | Waismed, Ltd. | 2002 | — |
| −4 | K043490 | PD-IO Disposable Intraosseous Infusion Needle | Vidacare Corporation | 2005 | — |
| −3 | K052195 | EZ-Mio Manual Driver | Vidacare Corporation | 2005 | — |
| −2 | K062956 | EZ-Mio, EZ-IO Distal Tibia | Vidacare Corporation | 2006 | — |
| −1 | K091140 | EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion… | Vidacare Corporation | 2009 | 1 |
| 0 (this device) | 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 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K051992 | Powered PD-IO Intraosseous Infusion SystemSummary page 1…ch we are claiming equivalenc [807.92(a (3)1: 5 10(k) Trade or Proprietary or Model Name Mnufacturer Number 1 K051992 1 Powered PD-IC Infusion System 1 Vidacare Corp. 2 K052408 2 EZ-10 Humneral… | 2005 |
| * | K052408 | EZ-IOSummary page 1…rietary or Model Name Mnufacturer Number 1 K051992 1 Powered PD-IC Infusion System 1 Vidacare Corp. 2 K052408 2 EZ-10 Humneral Head 2 Vidacare Corp. 3 K063142 3 Powered PD-I0… | 2005 |
| * | K063142 | Manual PD-IO; Powered PD-IOSummary page 1…wered PD-IC Infusion System 1 Vidacare Corp. 2 K052408 2 EZ-10 Humneral Head 2 Vidacare Corp. 3 K063142 3 Powered PD-I0 3 Vidacare Corp. Vidaport Intrao… | 2006 |
| * | K091140 | EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IOSummary page 1…. 3 K063142 3 Powered PD-I0 3 Vidacare Corp. Vidaport Intraosseous Infusion System K091 140 (formerly K032885); 4 4 EZ-I0 Humneral Head (formerly K052408; 4 Vidacare Corp… | 2009 |
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 |
|---|---|---|---|
| K132583 | EZ-IO Intraosseous Infusion System | 2014 | 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 18 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K132583 (Vidacare Corporation, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051992.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Powered PD-IO provides intraosseous access in the distal tibia of pediatric patients as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours. The Humeral Head EZ-l0 provides vascular access when standard venous access is not possible. Humeral head 10 access is indicated in pediatrics in e~rergent, urgent, or medically necessary cases when intravenous access is difficult or impossible to obtain for up to 24…
Read the full statement (116 words)
The Powered PD-IO provides intraosseous access in the distal tibia of pediatric patients as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours.
The Humeral Head EZ-l0 provides vascular access when standard venous access is not possible. Humeral head 10 access is indicated in pediatrics in e~rergent, urgent, or medically necessary cases when intravenous access is difficult or impossible to obtain for up to 24 hours.
The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours.The device is for use in pediatric patients (approximate weight range: 3kg-39kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101026 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101026: Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101026
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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