# K100099: Oral/Enteral Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Philips Children'S Medical Ventures
- Decided: Jun 14, 2010 after 152 days
- Product code: FPD (Tube, Feeding)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K801558 (1980). 10 ancestors in all.
35 later devices descend from it; 2 cite it directly.
1 of 46 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060944: Nutrisafe 2, Vygon Corp. (2006) Summary page 1.
- K082654: Enteral Only Extension Set, Respironics, Inc. (2008) Summary page 1.

## Most influential descendants
- K112434: BD Oral/Enteral Syringe with BD Univia Connection (2011), 33 descendants of its own
- K142128: Kangaroo Enteral Feeding Syringes with Enfit Connector (2015), 31 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
Oral/Enteral Syringes are intended for the delivery of liquid medication, formula, and breast milk. The patient population is neonates and infants. The environments for use are hospital and home environments by trained caregivers only. The Oral/Enteral Syringes are disposable and for single patient use only.

Source page: https://510kreport.com/device/K100099
Methodology: https://510kreport.com/methodology