# K811065: Piston Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: May 5, 1981 after 18 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K092986: Acacia Piston Syringe (2009), 0 descendants of its own
- K071027: Triboglide Lubricated Silicone-Free Syringe (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K811065
Methodology: https://510kreport.com/methodology
