Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sonendo, Inc. — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time

159 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K211995	Sonendo Filling Material 5C	Sonendo, Inc.	2021-08-27	60	0
K203302	GentleWave X	Sonendo, Inc.	2021-02-05	88	0
K190359	Sonendo GentleWave System	Sonendo, Inc.	2019-03-16	29	2
K181922	Sonendo Material A	Sonendo, Inc.	2018-10-22	96	0
K160905	Sonendo GentleWave System	Sonendo, Inc.	2016-06-03	63	0
K153157	Sonendo Gentle Wave System	Sonendo, Inc.	2016-01-29	88	0
K143448	Sonendo GentleWave System	Sonendo, Inc.	2015-05-01	150	0
K133752	SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICL	Sonendo, Inc.	2014-05-15	157	0
K130025	SONENDO ENDOTHERAPY SYSTEM	Sonendo, Inc.	2013-06-11	159	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda