# K082654: Enteral Only Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Nov 25, 2008 after 74 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- 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: 2 generations back to K801558 (1980). 6 ancestors in all.
40 later devices descend from it; 2 cite it directly.
1 of 47 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991918: Nutrisafe Extension Tube, Vygon Corp. (1999) Summary page 1.
- K973409: Kangaroo Enteral Feeding Extension Set for Syringe Pumps, Davis & Geck, Inc. (1998) Summary page 1.

## Most influential descendants
- K100099: Oral/Enteral Syringes (2010), 35 descendants of its own
- 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

## Indications for use
The Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which reduce the risk of accidental connection of an L.V. system to the enteral system, or the enteral system to an L.V. system.

Source page: https://510kreport.com/device/K082654
Methodology: https://510kreport.com/methodology