# K142377: The OnControl Bone Marrow Biopsy System by Vidacare

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare, LLC
- Decided: Dec 17, 2014 after 113 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K871390 (1987). 27 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 30 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072045: Oncontrol Bone Marrow Biopsy System, Vidacare Corporation (2007) Summary page 4.
- K070759: Powered EZ-IO Pediatric Bone Marrow Aspiration System, Vidacare Corporation (2007) Summary page 4.

## Most influential descendants
- K230015: OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver (2023), 0 descendants of its own
- K213896: BD Trek Powered Bone Biopsy System (2022), 0 descendants of its own

## Recalls of this device
- Nov 8, 2016 · Class II · Z-0679-2017: Sterility: Due to a potential incomplete seal on the outer sterile package.
- Nov 8, 2016 · Class II · Z-0678-2017: Sterility: Due to a potential incomplete seal on the outer sterile package.
- Nov 8, 2016 · Class II · Z-0675-2017: Sterility: Due to a potential incomplete seal on the outer sterile package.
- Nov 8, 2016 · Class II · Z-0676-2017: Sterility: Due to a potential incomplete seal on the outer sterile package.

## Indications for use
The OnControl Bone Marrow Biopsy System is intended for bone marrow aspiration and biopsy in adult and pediatric patients age 2 and older.

Source page: https://510kreport.com/device/K142377
Methodology: https://510kreport.com/methodology