# K140685: Endo Vac Apical Negative Pressure Irigation System

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Endo
- Decided: Jul 2, 2014 after 106 days
- Product code: NYL (Handpiece, Air-Powered, Root Canal Irrigation)
- Device class: 1
- Regulation: 21 CFR 872.4200
- 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 K052271 (2006). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052271: Rinsendo, Air Techniques, Inc. (2006) Summary page 4.

## Most influential descendants
- K211721: PS System (2021), 1 descendant of its own
- K233844: OdneClean (2024), 0 descendants of its own
- K162436: EndoVac Pure (2016), 0 descendants of its own

## Indications for use
The EndoVac® system is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.

Source page: https://510kreport.com/device/K140685
Methodology: https://510kreport.com/methodology