Zephyr Sleep Technologies: FDA filings under this applicant name
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Zephyr Sleep Technologies” (first 2012, latest 2020), plus 1 De Novo decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 138 days. Since 2017 the median was 129 days, against 171 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 459 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 129 |
| 2018 | 1 | 118 |
| 2019 | 2 | 125 |
| 2020 | 1 | 160 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zephyr Sleep Technologies took a median 129 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 171 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | 4 | 4 |
| LRK | Device, Anti-Snoring | 2 | 2 |
| QCJ | Closed Loop Auto Titration Device For Oral Appliances | 1 | 0 |
Review panels
- Anesthesiology (4)
- Dental (3)
Most recent Zephyr Sleep Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200695 | MATRx plus | MNR | 2020-08-24 | 160 |
| K191925 | MATRx Plus | MNR | 2019-10-29 | 103 |
| K190051 | TD Clip | LRK | 2019-06-07 | 147 |
| K181996 | MATRx Plus | MNR | 2018-11-21 | 118 |
| K163665 | MATRx plus | MNR | 2017-05-05 | 129 |
| K103704 | REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP | LRK | 2012-03-23 | 459 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170090 | De Novo | Closed Loop Auto Titration Device For Oral Appliances | 2018-08-23 |
Recalls
openFDA lists no recalls under a recalling firm named Zephyr Sleep Technologies.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Zephyr Sleep Technologies is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03812692: Validation of a Simplified MATRx Plus (Completed, started 2019-02-06)
- NCT03579225: Improving the Efficiency of the Digital Sleep Workflow Using MATRx Plus (Completed, started 2018-07-01)
- NCT03616327: Workflow Validation of an In-Home Feedback Controlled Mandibular Positioner (Completed, started 2017-11-01)
- NCT03627169: PSG Validation of MATRx Plus AHI (Completed, started 2017-07-25)
- NCT03217383: Predictive Accuracy of MATRx Plus in Identifying Favorable Candidates for Oral Appliance Therapy (Completed, started 2017-07-10)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Zephyr Sleep Technologies (5)
- Zephyr Sleep Technologies, Inc. (2)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Zephyr Technology Corporation (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zephyr Sleep Technologies?
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Zephyr Sleep Technologies” (first 2012, latest 2020), plus 1 De Novo decision, across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zephyr Sleep Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zephyr Sleep Technologies is 138 days. Since 2017: 129 days, versus 171 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zephyr Sleep Technologies?
The most frequent FDA product codes under this applicant name are MNR (Ventilatory Effort Recorder, 4); LRK (Device, Anti-Snoring, 2); QCJ (Closed Loop Auto Titration Device For Oral Appliances, 1).
Next steps
- See all 6 Zephyr Sleep Technologies clearances with predicates and recalls
- Run predicate analysis for product code MNR, Zephyr Sleep Technologies's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.