510(k) · Cleared
ClearedManual PD-IO; Powered PD-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 Dec 8, 2006 as substantially equivalent to K043490 (Vidacare Corporation, 2005) and 2 other predicates after a 53-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.
- Decided
- Dec 8, 2006
- Review
- 53 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K915409 (1992). 7 ancestors in all, the oldest K913258 (1992). 2 later devices descend 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 backK051992 Powered PD-IO Intraosseous Infusion SystemVidacare Corporation · 2005
- This deviceK063142 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 2 of 2 · See allView 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 | K051992 | Powered PD-IO Intraosseous Infusion System | Vidacare Corporation | 2005 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (3)
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 2…and powered drivers include two different drivers. The same needle set is used for both drivers. The Manual PD-IO, previously cleared under 510(k) K043490, consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The manual driv… | 2005 |
| * | K051992 | Powered PD-IO Intraosseous Infusion SystemSummary page 2…izing the same technique and device previously cleared for the proximal tibia via 510(k) K043490. The Powered PD-1O,previously cleared under 510(k) K051992 for pediatric use, consists of a reusable battery powered driver connected to a single use disposable intraosseous… | 2005 |
| * | K913258 | Disposable Introsseous Infusion NeedlesSummary page 3…exact same technology for use as the Powered PD-TO (K051992). Vidacare also wishes to use as a predicate Disposable Intraosseous Infusion Needles, K913258, by Cook, Inc., as these needles have the exact same indications for use for which we are applying. These needles a… | 1992 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101026 | Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO | 2010 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K101026 (Vidacare Corporation, 2010) has gone furthest, with 1 descendant 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 Manual PD-IO, and Powered PD-1O provide intraosseous access in
the distal tibia of pediatric patients as an alternative to IV access
during emergencies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063142: Manual PD-IO; Powered PD-IO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063142
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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