Earlysense, Ltd.: FDA clearances and approvals
Earlysense, Ltd. has 12 FDA 510(k) clearances (first 2007, latest 2018), across 2 product codes in 2 review panels. Median 510(k) review time: 197 days. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 94 |
| 2013 | 1 | 218 |
| 2014 | 1 | 196 |
| 2015 | 1 | 138 |
| 2016 | 1 | 217 |
| 2017 | 0 | — |
| 2018 | 1 | 198 |
| 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, Earlysense, Ltd.'s cleared 510(k)s took a median 198 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 202 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | 8 | 8 |
| MSX | System, Network And Communication, Physiological Monitors | 4 | 4 |
Review panels
- Anesthesiology (8)
- Cardiovascular (4)
Most recent Earlysense, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171836 | EarlySense Bed Sensing Unit | BZQ | 2018-01-04 | 198 |
| K152911 | EarlySense Insight Sytem | BZQ | 2016-05-06 | 217 |
| K151006 | EarlySense Central Display Station (CDS) | MSX | 2015-08-31 | 138 |
| K133661 | CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM | BZQ | 2014-06-13 | 196 |
| K131379 | EARLYSENSE | BZQ | 2013-12-18 | 218 |
| K121885 | EARLYSENSE CENTRAL DISPLAY SYSTEM | MSX | 2012-09-10 | 74 |
| K120465 | EARLYSENSE (EVERON) SYSTEM | BZQ | 2012-06-08 | 114 |
| K110521 | EVERON CENTRAL DISPLAY STATION (CDS) | MSX | 2011-04-19 | 55 |
| K100376 | EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 | MSX | 2010-08-06 | 175 |
| K092062 | EVERON 1.0 | BZQ | 2010-05-24 | 320 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Earlysense, Ltd..
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.
Device clinical trials
Earlysense, Ltd. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02641327: Monitoring Changes in Blood Pressure (Completed, started 2015-12)
- NCT02659982: Evaluation of EarlySense Home Care Tele-monitoring Device -For Early Detection of Deterioration For Cardiac Patients at Home (Completed, started 2015-04)
Frequently asked questions
How many FDA 510(k) clearances does Earlysense, Ltd. have?
Earlysense, Ltd. has 12 FDA 510(k) clearances (first 2007, latest 2018), across 2 product codes in 2 review panels.
How long does FDA take to clear Earlysense, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Earlysense, Ltd.'s cleared 510(k)s is 197 days.
What devices does Earlysense, Ltd. make?
Its most frequent FDA product codes are BZQ (Monitor, Breathing Frequency, 8); MSX (System, Network And Communication, Physiological Monitors, 4).
Has Earlysense, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Earlysense, Ltd. Related entities may recall under other names.
Next steps
- See all 12 Earlysense, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BZQ, Earlysense, Ltd.'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.