Sotera Wireless, Inc.: FDA clearances and approvals
Sotera Wireless, Inc. has 9 FDA 510(k) clearances (first 2012, latest 2018), across 2 product codes in 1 review panel. Median 510(k) review time: 117 days. openFDA lists 2 product recalls by a recalling firm named Sotera Wireless, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 120 |
| 2013 | 2 | 116 |
| 2014 | 0 | — |
| 2015 | 4 | 97 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 117 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Sotera Wireless, Inc.'s cleared 510(k)s took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 7 | 7 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
Review panels
- Cardiovascular (9)
Most recent Sotera Wireless, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180472 | ViSi Mobile Monitoring System | MHX | 2018-06-19 | 117 |
| K152341 | ViSi Mobile Monitoring System | MWI | 2015-12-14 | 117 |
| K142827 | Visi Mobile Monitoring System, Visi Mobile Chest Sensor | MHX | 2015-07-20 | 293 |
| K150361 | ViSi Mobile Monitoring System | MWI | 2015-04-30 | 77 |
| K143751 | Visi Mobile Monitoring System | MWI | 2015-01-23 | 23 |
| K133586 | VISI MOBILE MONITIORING SYSTEM | MWI | 2013-12-18 | 27 |
| K130709 | VISI MOBILE MONITORING SYSTEM | MWI | 2013-10-07 | 206 |
| K122036 | VISI MOBILE MONITORING SYSTEM | MWI | 2012-08-15 | 35 |
| K112478 | VISI MOBILE MONITORING SYSTEM | MWI | 2012-03-22 | 206 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-05-23.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sotera Wireless, Inc. have?
Sotera Wireless, Inc. has 9 FDA 510(k) clearances (first 2012, latest 2018), across 2 product codes in 1 review panel.
How long does FDA take to clear Sotera Wireless, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sotera Wireless, Inc.'s cleared 510(k)s is 117 days.
What devices does Sotera Wireless, Inc. make?
Its most frequent FDA product codes are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 7); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 2).
Has Sotera Wireless, Inc. had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Sotera Wireless, Inc; the most recent began 2013-05-23. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 9 Sotera Wireless, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MWI, Sotera Wireless, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.