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

Sotera Wireless, Inc. — Predicate Candidate Screening

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

117 daysmedian FDA review time

293 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K180472	ViSi Mobile Monitoring System	Sotera Wireless, Inc.	2018-06-19	117	0
K152341	ViSi Mobile Monitoring System	Sotera Wireless, Inc.	2015-12-14	117	0
K142827	Visi Mobile Monitoring System, Visi Mobile Chest Sensor	Sotera Wireless, Inc.	2015-07-20	293	0
K150361	ViSi Mobile Monitoring System	Sotera Wireless, Inc.	2015-04-30	77	0
K143751	Visi Mobile Monitoring System	Sotera Wireless, Inc.	2015-01-23	23	0
K133586	VISI MOBILE MONITIORING SYSTEM	Sotera Wireless, Inc.	2013-12-18	27	0
K130709	VISI MOBILE MONITORING SYSTEM	Sotera Wireless, Inc.	2013-10-07	206	0
K122036	VISI MOBILE MONITORING SYSTEM	Sotera Wireless, Inc.	2012-08-15	35	2
K112478	VISI MOBILE MONITORING SYSTEM	Sotera Wireless, Inc.	2012-03-22	206	2

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