# K953064: Bioaccess Marrow Harvest System

- Pathway: 510(k) (Traditional)
- Applicant: Bioaccess, Inc.
- Decided: Aug 7, 1995 after 38 days
- Product code: GDM (Needle, Aspiration And Injection, Reusable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K072045: Oncontrol Bone Marrow Biopsy System (2007), 7 descendants of its own
- K081713: Vertebral Access System by Vidacare (2008), 4 descendants of its own
- K112468: The Oncontrol Bone Access System by Vidacare (2011), 3 descendants of its own
- K142377: The OnControl Bone Marrow Biopsy System by Vidacare (2014), 2 descendants of its own
- K113872: The Oncontrol Bone Access and Bone Biopsy System by Vidacare (2012), 2 descendants of its own

Source page: https://510kreport.com/device/K953064
Methodology: https://510kreport.com/methodology