FDA applicant
Sotera Wireless, Inc.
FDA records 9 decisions for Sotera Wireless, Inc. (San Diego, CA) from 2012 to 2018: 9 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and MHX (Monitor, Physiological, Patient (With…). Its devices cite 19 predicates, 10 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sotera Wireless, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
2in 2013
Class I Class II/III not classified
Planning a device like Sotera Wireless, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report