# K883955: Single-Fil (TM) Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Oct 17, 1988 after 28 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
No predicates in its family tree.
9 later devices descend from it; 1 cites 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
- K042934: 1BD Soloshot IX Syringe (2004), 8 descendants of its own
- 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

Source page: https://510kreport.com/device/K883955
Methodology: https://510kreport.com/methodology