510(k) · Cleared
ClearedPowered EZ-IO Pediatric Bone Marrow Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vidacare Corporation · FCF Instrument, Biopsy, Mechanical, Gastrointestinal
Cleared on May 21, 2007 as substantially equivalent to K062833 (Vidacare Corporation, 2006) and 2 other predicates after a 62-day review. Its family tree reaches back 6 generations to 1987. 1 of the 26 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- May 21, 2007
- Review
- 62 days
- Class
- Class II
- Product code
- FCF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K871390 (1987). 22 ancestors in all. 3 later devices descend from it, 1 citing it directly. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
- 5 generations backK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
- 4 generations backK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
- 3 generations backK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998 · Recalled
- 2 generations backK990839 Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999
- 1 generation backK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
- This deviceK070759 Powered EZ-IO Pediatric Bone Marrow Aspiration SystemVidacare Corporation · 2007
- Descendant · cites it directly · 2 of its ownK142377 The OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK230015 OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone…Laurane Medical Sas · 2023
- Descendant · 2 generations on · 0 of its ownK213896 BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular · 2022
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrow2 generations back · 1998
Most influential descendants
Showing 3 of 3 · See all- K142377The OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC · 2014 · cites it directly2descendants
- K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…Laurane Medical Sas · 2023 · 2 generations on0descendants
- K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K871390 | Bard Biopty Biopsy System | C.R. Bard, Inc. | 1987 | — |
| −5 | K962969 | Medical Device Technologies, Inc.Ultra | Medical Device Technologies, Inc. | 1996 | — |
| −4 | K982085 | Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy… | Medical Device Technologies, Inc. | 1998 | — |
| −3 | K982960 | Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument | Medical Device Technologies, Inc. | 1998 | 2 |
| −2 | K990839 | Tru-Core I Reusable Biopsy Instrument | Medical Device Technologies, Inc. | 1999 | — |
| −1 | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut… | Sterylab S.R.L. | 2005 | — |
| 0 (this device) | K070759 | Powered EZ-IO Pediatric Bone Marrow Aspiration System | Vidacare Corporation | 2007 | — |
| +1 | K142377 | The OnControl Bone Marrow Biopsy System by Vidacare | Vidacare, LLC | 2014 | 4 |
| +2 | K230015 | OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit… | Laurane Medical Sas | 2023 | — |
| +2 | K213896 | BD Trek Powered Bone Biopsy System | Bard Peripheral Vascular | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 1 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062833 | Powered EZ-IO Bone Marrow Aspiration SystemSummary page 2…Powered EZ-IO® Pediatric Bone Marrow Aspiration System consists of a reusable battery powered driver [previously cleared for aspiration in adults via 510(k) K062833], and a 25mm intraosseous (IO) device [cleared under 510(k) K032885] connected to a disposable, single use intraosseo… | 2006 |
| * | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Summary page 1…r Proprietary or Model Name Mnufacturer 11 K62833 1 Powered EZ-l0 Bone Marrow 1 Vidacare Corp. IAspiration System 2 K051 506 12 MIELO-CAN® 2 Sterylab 3K3853 VidaPort lntraossecous Infusion System 3 Vidacare Corp.… | 2005 |
| Kept off the family tree | K003853 | FDA’s K003853 is Infinion 1.5T MR Imaging System, Model Mri 100 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K032885 | Vidaport Intraosseous Infusion SystemSummary page 2…a reusable battery powered driver [previously cleared for aspiration in adults via 510(k) K062833], and a 25mm intraosseous (IO) device [cleared under 510(k) K032885] connected to a disposable, single use intraosseous aspiration needle set assembly. Upon activation, the drill assist… | 2004 |
| Kept off the family tree | K005924 | Powered Pediatric IO Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142377 | The OnControl Bone Marrow Biopsy System by Vidacare | 2014 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K142377 (Vidacare, LLC, 2014) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K062833.
How does its category compare?
All FCF devicesFCF Instrument, Biopsy, Mechanical, Gastrointestinal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FCF
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · FCF
Too few FCF 510(k)s in any year since 2007 to give a median.
Recalls per year · FCF
No recall names FCF since 2007.
Adverse event reports per year · FCF
No MAUDE report names FCF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070759: Powered EZ-IO Pediatric Bone Marrow Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070759
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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