# K953463: Vacutainer Plus Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vacutainer Systems
- Decided: Sep 20, 1995 after 58 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 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
- K972075: Vacutainer Brand PPT Plasma Preparation Tube (1998), 13 descendants of its own
- K110701: Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 (2011), 6 descendants of its own
- K141410: Oragene DX Ogd-500.001 (2015), 3 descendants of its own
- K152556: Oragene Dx (2016), 2 descendants of its own
- K192920: Oragene®•Dx (2020), 1 descendant of its own

Source page: https://510kreport.com/device/K953463
Methodology: https://510kreport.com/methodology