# K042934: 1BD Soloshot IX Syringe

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Oct 28, 2004 after 3 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: 1 generation back to K883955 (1988). 1 ancestor in all.
8 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)
- K883955: Single-Fil (TM) Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1988) Summary page 1.

## Most influential descendants
- K201234: BD SoloShot Mini Syringe/ BD Auto Disable Syringe (2020), 5 descendants of its own
- 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
- K091377: BD Flu+ Syringe (2009), 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

## Indications for use
The BD SoloShotTM IX Syringes are intended for the aspiration and injection of fluids.

Source page: https://510kreport.com/device/K042934
Methodology: https://510kreport.com/methodology