Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sleeping Well, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
264 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213088 | ZQuiet Advance | Sleeping Well, LLC | 2022-06-15 | 264 | 0 |
| K180124 | ZQuiet | Sleeping Well, LLC | 2018-06-12 | 147 | 0 |
| K140777 | ZQUIET-SA | Sleeping Well, LLC | 2014-07-25 | 119 | 0 |
| K122475 | ZQUIET PRO-PLUS | Sleeping Well, LLC | 2012-12-07 | 115 | 0 |
| K093407 | ZQUIET MOUTHPIECE | Sleeping Well, LLC | 2010-06-22 | 232 | 0 |
| K090503 | ZQUIET MOUTHPIECE | Sleeping Well, LLC | 2009-03-10 | 13 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda