# K211721: PS System

- Pathway: 510(k) (Traditional)
- Applicant: Inter-Med, Inc.
- Decided: Dec 2, 2021 after 181 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: 2 generations back to K052271 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140685: Endo Vac Apical Negative Pressure Irigation System, Sybron Endo (2014) Summary page 4.

## Most influential descendants
- K233844: OdneClean (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K211721
Methodology: https://510kreport.com/methodology