# K131177: Sinuflush Lavage System

- Pathway: 510(k) (Traditional)
- Applicant: Hedgepath, LLC
- Decided: Sep 20, 2013 after 148 days
- Product code: KAR (Irrigator, Sinus)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sinusense Nasal Rinse: named in the summary without a submission number

## Indications for use
The SinuFlush Lavage System is intended for nasal and sinus irrigation in patients who are under the care of a physician. The SinuFlush Lavage System is a prescription use product that is to be used by adults in either the physician’s office or in the home after obtaining instructions from a health care provider.

Source page: https://510kreport.com/device/K131177
Methodology: https://510kreport.com/methodology