510(k) · Cleared
ClearedPureSleep (OTC use)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleep Science Partners, Inc. · LRK Device, Anti-Snoring
Cleared on Apr 11, 2019 after a 90-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Apr 11, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK190058 PureSleep (OTC use)Sleep Science Partners, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK220688 SilentZPro 2.0Shinrin-Yoku Traders, LLC · 2022
- Descendant · cites it directly · 1 of its ownK213088 ZQuiet AdvanceSleeping Well, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK253868 QuietLab ProQuietLab, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK250028 Anti Snore MouthpieceDongguan Yiyao Science & Technology Development Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK222475 Snor LockSolbaro Co., Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K220688SilentZPro 2.0Shinrin-Yoku Traders, LLC · 2022 · cites it directly1descendant
- K213088ZQuiet AdvanceSleeping Well, LLC · 2022 · cites it directly1descendant
- K253868QuietLab ProQuietLab, LLC · 2025 · 2 generations on0descendants
- K250028Anti Snore MouthpieceDongguan Yiyao Science & Technology Development Co., Ltd. · 2025 · 2 generations on0descendants
- K222475Snor LockSolbaro Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190058 | PureSleep (OTC use) | Sleep Science Partners, Inc. | 2019 | — |
| +1 | K220688 | SilentZPro 2.0 | Shinrin-Yoku Traders, LLC | 2022 | — |
| +1 | K213088 | ZQuiet Advance | Sleeping Well, LLC | 2022 | — |
| +2 | K253868 | QuietLab Pro | QuietLab, LLC | 2025 | — |
| +2 | K250028 | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. | 2025 | — |
| +1 | K222475 | Snor Lock | Solbaro Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K220688 (Shinrin-Yoku Traders, LLC, 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
https://510kreport.com/device/K190058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190058: PureSleep (OTC use).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190058
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026