# K092908: Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO

- Pathway: 510(k) (Traditional)
- Applicant: Neomed, Inc.
- Decided: Mar 10, 2010 after 169 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 K951871 (1995). 1 ancestor in all.
37 later devices descend from it; 1 cites 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)
- K951871: Piston Syringe, Baxa Corp. (1995). Our OCR of the scanned summary read K851871, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words. Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The device is indicated for use as a dispenser, a measuring 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/K092908
Methodology: https://510kreport.com/methodology