# K951871: Piston Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Baxa Corp.
- Decided: Jun 21, 1995 after 61 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.
39 later devices descend from it; 2 cite it directly.
1 of 40 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K092908: Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO (2010), 37 descendants of its own
- K122373: Neomed Oral/Enteral Syringe (2012), 36 descendants of its own
- K143344: NeoMed NeoConnect Enteral Syringes with ENFit Connector (2015), 34 descendants of its own
- K152857: NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps (2015), 30 descendants of its own
- K161039: NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) (2016), 21 descendants of its own

Source page: https://510kreport.com/device/K951871
Methodology: https://510kreport.com/methodology