510(k) · Cleared
ClearedHushd Pro Avera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Good Sleep CO Pte, Ltd. · LRK Device, Anti-Snoring
Cleared on May 9, 2024 as substantially equivalent to K143244 (Panthera Dental, Inc., 2014) after a 307-day review. Its family tree reaches back 6 generations to 1989. 1 later device descends from it.
- Decided
- May 9, 2024
- Review
- 307 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K882303 (1989). 10 ancestors in all, the oldest K880956 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 4 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 3 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 2 generations backK113201 Narval CCResmed Sas · 2011
- 1 generation backK143244 The Panthera Anti-Snoring DevicePanthera Dental, Inc. · 2014
- This deviceK232025 Hushd Pro AveraGood Sleep CO Pte, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK251784 Hushd Pro Z-LinkGood Sleep CO Pte, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251784Hushd Pro Z-LinkGood Sleep CO Pte, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −5 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −4 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −3 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −2 | K113201 | Narval CC | Resmed Sas | 2011 | — |
| −1 | K143244 | The Panthera Anti-Snoring Device | Panthera Dental, Inc. | 2014 | — |
| 0 (this device) | K232025 | Hushd Pro Avera | Good Sleep CO Pte, Ltd. | 2024 | — |
| +1 | K251784 | Hushd Pro Z-Link | Good Sleep CO Pte, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143244 | The Panthera Anti-Snoring DeviceSummary page 5…I Classification Panel: Dental Products Panel Reviewing Branch Dental Devices Branch PRIDICATE DEVICE Predicate Device: K143244 The Panthera Anti- Panthera Dental, Inc. Snoring Device Reference Dev… | 2014 |
| † | K133683 | MICR02 Osa Device | 2014 |
| † | K220330 | Soundly Anti Snoring Device | 2022 |
| † | K171576 | The Panthera Anti-Snoring X3 Device | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251784 | Hushd Pro Z-Link | 2025 | 0 |
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?
- The line of descent spans 35 years and passes through 7 companies; a new generation was cleared every 7.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K251784 (Good Sleep CO Pte, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K143244.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 | — |
What is it indicated for?
The Hushd Pro Avera device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea
(OSA) in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232025: Hushd Pro Avera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232025
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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