Signifier Medical Technologies, Ltd.: FDA clearances and approvals
Signifier Medical Technologies, Ltd. has 2 FDA 510(k) clearances (first 2023, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 82 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 |
|---|---|---|
| 2023 | 1 | 64 |
| 2024 | 1 | 101 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Signifier Medical Technologies, Ltd.'s cleared 510(k)s took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 82 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QNO | Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea | 3 | 2 |
Review panels
- Dental (3)
Most recent Signifier Medical Technologies, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | QNO | 2024-05-16 | 101 |
| K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | QNO | 2023-01-18 | 64 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200018 | De Novo | Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea | 2021-02-05 |
Recalls
openFDA lists no recalls under a recalling firm named Signifier Medical Technologies, 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
Signifier Medical Technologies, Ltd. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05252156: eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea (Completed, started 2022-03-21)
- NCT03829956: Intraoral Tongue Stimulation for Treatment of Primary Snoring (Completed, started 2019-02-04)
Frequently asked questions
How many FDA 510(k) clearances does Signifier Medical Technologies, Ltd. have?
Signifier Medical Technologies, Ltd. has 2 FDA 510(k) clearances (first 2023, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Signifier Medical Technologies, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Signifier Medical Technologies, Ltd.'s cleared 510(k)s is 82 days.
What devices does Signifier Medical Technologies, Ltd. make?
Its most frequent FDA product codes are QNO (Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea, 3).
Has Signifier Medical Technologies, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Signifier Medical Technologies, Ltd. Related entities may recall under other names.
Next steps
- See all 2 Signifier Medical Technologies, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QNO, Signifier Medical Technologies, 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.