# K201234: BD SoloShot Mini Syringe/ BD Auto Disable Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jul 15, 2020 after 69 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883955 (1988). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042934: 1BD Soloshot IX Syringe, Becton, Dickinson & CO (2004) Summary page 4.

## Most influential descendants
- K210464: Auto Disable Syringe (2021), 2 descendants of its own
- K212920: Sterile Safety Syringe with Needle for Single Use,  Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use (2022), 1 descendant of its own
- K260514: Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle (2026), 0 descendants of its own
- K234024: HWJECT Auto-disable syringe (2024), 0 descendants of its own
- K231519: Revital Cady (2023), 0 descendants of its own

## Indications for use
The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is intended for aspiration and injection of fluids.

Source page: https://510kreport.com/device/K201234
Methodology: https://510kreport.com/methodology