Sleeping Well, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sleeping Well, LLC” (first 2009, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 133 days. 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 | 115 |
| 2013 | 0 | — |
| 2014 | 1 | 119 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 147 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 264 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sleeping Well, LLC took a median 206 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LRK | Device, Anti-Snoring | 6 | 6 |
Review panels
- Dental (6)
Most recent Sleeping Well, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213088 | ZQuiet Advance | LRK | 2022-06-15 | 264 |
| K180124 | ZQuiet | LRK | 2018-06-12 | 147 |
| K140777 | ZQUIET-SA | LRK | 2014-07-25 | 119 |
| K122475 | ZQUIET PRO-PLUS | LRK | 2012-12-07 | 115 |
| K093407 | ZQUIET MOUTHPIECE | LRK | 2010-06-22 | 232 |
| K090503 | ZQUIET MOUTHPIECE | LRK | 2009-03-10 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Sleeping Well, LLC.
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 Sleeping Well, LLC?
FDA lists 6 510(k) clearances under the applicant name “Sleeping Well, LLC” (first 2009, latest 2022), across 1 product code 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 Sleeping Well, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sleeping Well, LLC is 133 days.
Which FDA product codes appear under Sleeping Well, LLC?
The most frequent FDA product codes under this applicant name are LRK (Device, Anti-Snoring, 6).
Next steps
- See all 6 Sleeping Well, LLC clearances with predicates and recalls
- Run predicate analysis for product code LRK, Sleeping Well, LLC'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.