# K122373: Neomed Oral/Enteral Syringe

- Pathway: 510(k) (Special)
- Applicant: Neomed, Inc.
- Decided: Sep 20, 2012 after 45 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 K951871 (1995). 2 ancestors in all.
36 later devices descend from it; 3 cite it directly.
1 of 39 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092908: Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO, Neomed, Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- K183540: Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) (2019), 5 descendants of its own
- K160419: Monoject Enteral Feeding Syringe with ENFit Connector (2016), 4 descendants of its own

## Indications for use
The device is indicated for use as a dispenser, a mneasuring device and an oral fluid transfer device. It is used to inject fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.

Source page: https://510kreport.com/device/K122373
Methodology: https://510kreport.com/methodology