Sleepnet Corporation: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Sleepnet Corporation” (first 1996, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 116 days. Since 2017 the median was 129 days, against 238 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 | 3 | 163 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 146 |
| 2020 | 0 | — |
| 2021 | 1 | 142 |
| 2022 | 1 | 258 |
| 2023 | 0 | — |
| 2024 | 5 | 30 |
| 2025 | 0 | — |
| 2026 | 1 | 213 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sleepnet Corporation 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 238 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 18 | 18 |
| CBK | Ventilator, Continuous, Facility Use | 4 | 4 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
Review panels
- Anesthesiology (23)
Most recent Sleepnet Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | BZD | 2026-01-15 | 213 |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | BZD | 2024-10-18 | 116 |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | CBK | 2024-08-28 | 57 |
| K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | BZD | 2024-07-10 | 30 |
| K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask | CBK | 2024-06-27 | 29 |
| K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | BZD | 2024-06-15 | 22 |
| K211274 | iQ 2 Nasal Mask, Phantom 2 Nasal Mask | BZD | 2022-01-10 | 258 |
| K203601 | Innova Nasal Non-Vented Mask | BZD | 2021-04-30 | 142 |
| K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented | CBK | 2019-07-26 | 144 |
| K190254 | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask | BZD | 2019-07-05 | 148 |
13 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 1 recall events; 7 initiated in the last five years. Most recent: 2024-03-01.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sleepnet Corporation?
FDA lists 23 510(k) clearances under the applicant name “Sleepnet Corporation” (first 1996, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sleepnet Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sleepnet Corporation is 116 days. Since 2017: 129 days, versus 238 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sleepnet Corporation?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 18); CBK (Ventilator, Continuous, Facility Use, 4); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 1).
Next steps
- See all 23 Sleepnet Corporation clearances with predicates and recalls
- Run predicate analysis for product code BZD, Sleepnet Corporation'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.