510(k) · Cleared
ClearedHumeral Head, 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 7, 2006 as substantially equivalent to K052195 (Vidacare Corporation, 2005) and 1 other predicate after an 81-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Nov 7, 2006
- Review
- 81 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K915409 (1992). 8 ancestors in all, the oldest K913258 (1992). No later device cites it as a predicate yet.
- 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 backK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
- This deviceK062422 Humeral Head, Manual DriverVidacare Corporation · 2006
View 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 | K052195 | EZ-Mio Manual Driver | Vidacare Corporation | 2005 | — |
| 0 (this device) | K062422 | Humeral Head, Manual Driver | Vidacare Corporation | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K052195 | EZ-Mio Manual DriverSummary page 1…ng equivalence [807.92(a)(3)]: 510(k) Trade or Proprietary or Manufacturer Number Model Name 1 K052195 1 EZ-MIO Manual Driver 1 Vidacare Corp. 2 K052408 2 EZ-IO Humneral Head 2 V… | 2005 |
| * | K052408 | EZ-IOSummary page 1…ary or Manufacturer Number Model Name 1 K052195 1 EZ-MIO Manual Driver 1 Vidacare Corp. 2 K052408 2 EZ-IO Humneral Head 2 Vidacare Corp. Description of the device: The Humeral Head, Manual Driv… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 1 of the 8 ancestors has a recall of any class.
- 4 other devices also cite its predicate K052195.
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 Humeral Head, Manual Driver is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062422 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062422: Humeral Head, Manual Driver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062422
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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