510(k) · Cleared
Recalled · Class II · 2015The T.a.L.O.N. Intraossous Infusion System by Vidacre
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 Jun 3, 2012 as substantially equivalent to K063567 (Vidacare Corporation, 2007) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 1992. It has been recalled once.
- Decided
- Jun 3, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K915409 (1992). 10 ancestors in all, the oldest K883014 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK915409 Intraosseous Access NeedleCook, Inc. · 1992
- 4 generations backK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
- 3 generations backK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
- 2 generations backK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
- 1 generation backK063567 EZ-Mio SternalVidacare Corporation · 2007
- This deviceK120661 The T.a.L.O.N. Intraossous Infusion System by VidacreVidacare Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915409 | Intraosseous Access Needle | Cook, Inc. | 1992 | — |
| −4 | K022415 | Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST | Waismed, Ltd. | 2002 | — |
| −3 | K043490 | PD-IO Disposable Intraosseous Infusion Needle | Vidacare Corporation | 2005 | — |
| −2 | K052195 | EZ-Mio Manual Driver | Vidacare Corporation | 2005 | — |
| −1 | K063567 | EZ-Mio Sternal | Vidacare Corporation | 2007 | — |
| 0 (this device) | K120661 | The T.a.L.O.N. Intraossous Infusion System by Vidacre | Vidacare Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K063567 | EZ-Mio SternalSummary page 1…uivalenc [807.92(a) (3)]: 5 10(k) Trade or Propriletary or Model Date of Mnfcue Number Name Concurrence Mnfcue K063567 EZ-MIO Sternal January 26, 2007 Vidacare Corp. K970380 F.A.S.T.1 lntraosseous I… | 2007 |
| * | K970380 | F.a.S.T. 1 Intraosseous Infusion SystemSummary page 1…nfcue Number Name Concurrence Mnfcue K063567 EZ-MIO Sternal January 26, 2007 Vidacare Corp. K970380 F.A.S.T.1 lntraosseous Infusion April 25, 1997 PYNG Medical _____System… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2015 | Class II | Z-1801-2015 | Device Design | Potential breach in sterility |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Sternal IO Access is indicated for adult patients when rapid fluid or pharmacological resuscitation is required in emergencies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120661 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120661: The T.a.L.O.N. Intraossous Infusion System by Vidacre.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120661
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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