510(k) · Cleared
ClearedPowered EZ-IO 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 Nov 30, 2006 as substantially equivalent to K032885 (Vidacare Corporation, 2004) and 1 other predicate after a 70-day review. Its family tree reaches back 3 generations to 1989. 1 of the 24 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Nov 30, 2006
- Review
- 70 days
- Class
- Class II
- Product code
- FCF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K890925 (1989). 9 ancestors in all. 14 later devices descend from it, 3 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 2 generations backK961959 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996
- 1 generation backK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Recalled (Class I)
- This deviceK062833 Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006
- Descendant · cites it directly · 7 of its ownK072045 Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 2007
- Descendant · 2 generations on · 4 of its ownK081713 Vertebral Access System by VidacareVidacare Corporation · 2008
- Descendant · cites it directly · 4 of its ownK071732 MarrowminerStemcor Systems, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK152474 Avitus Bone HarvesterAvitus Orthopaedics, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 3 of its ownK112468 The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc. · 2011
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrowdirect predicate · 1998
Most influential descendants
Showing 5 of 14 · See all- K072045Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 2007 · cites it directly7descendants
- K081713Vertebral Access System by VidacareVidacare Corporation · 2008 · 2 generations on4descendants
- K071732MarrowminerStemcor Systems, Inc. · 2007 · cites it directly4descendants
- K152474Avitus Bone HarvesterAvitus Orthopaedics, Inc. · 2015 · 2 generations on3descendants
- K112468The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc. · 2011 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −2 | K961959 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1996 | — |
| −1 | K980196 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1998 | Class I |
| 0 (this device) | K062833 | Powered EZ-IO Bone Marrow Aspiration System | Vidacare Corporation | 2006 | — |
| +1 | K072045 | Oncontrol Bone Marrow Biopsy System | Vidacare Corporation | 2007 | — |
| +2 | K081713 | Vertebral Access System by Vidacare | Vidacare Corporation | 2008 | — |
| +1 | K071732 | Marrowminer | Stemcor Systems, Inc. | 2007 | — |
| +2 | K152474 | Avitus Bone Harvester | Avitus Orthopaedics, Inc. | 2015 | 1 |
| +3 | K112468 | The Oncontrol Bone Access System by Vidacare | Regulatory Specialists, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K032885 | Vidaport Intraosseous Infusion SystemSummary page 1…ng equivalence [807.92(a)(3)]: 510(k) Number _Name Trade or Proprietary or Model Mnfcue 1 K032885 1 VidaPort Intraosseous Infusion 1 VidaCare Corp. Mnfcue… | 2004 |
| * | K980196 | MD Tech Biopsy Set for Bone and Bone MarrowSummary page 1…Mnfcue System _ _ _ _ _ _ _ _ _ _ 2 K980 196 2 Manian Biopsy Set for Bone 2 Medical Device ________ and bone Marrow Technologi… | 1998 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K072045 (Vidacare Corporation, 2007) has gone furthest, with 7 descendants of its own.
- 7 other devices also cite its predicate K032885.
How does its category compare?
All FCF devicesFCF Instrument, Biopsy, Mechanical, Gastrointestinal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062833: Powered EZ-IO 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/K062833
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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