510(k) · Cleared
ClearedSnoreRx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apnea Sciences Corporation · LRK Device, Anti-Snoring
Cleared on Aug 9, 2016 as substantially equivalent to K112205 (Consumer Health Products, Inc., 2011) after a 279-day review. Its family tree reaches back 4 generations to 2007. 22 later devices descend from it.
- Decided
- Aug 9, 2016
- Review
- 279 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K071404 (2007). 9 ancestors in all, the oldest K882303 (1989). 22 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- 3 generations backK100545 SleeprightPower Products, Inc.-Splintek · 2010
- 2 generations backK103004 Snore GuardRanir, LLC · 2011
- 1 generation backK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- This deviceK153200 SnoreRxApnea Sciences Corporation · 2016
- Descendant · cites it directly · 21 of its ownK170825 SnoreRxApnea Sciences Corporation · 2017
- Descendant · 2 generations on · 3 of its ownK233850 Difiney Anti Snoring DeviceFissiontech, LLC · 2024
- Descendant · 2 generations on · 3 of its ownK191618 SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019
- Descendant · 2 generations on · 2 of its ownK200657 SmartGuard Anti-Snoring DeviceSmartguard Rx, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK253845 Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB…Ram.Shaw Pte., Ltd. · 2026
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K170825SnoreRxApnea Sciences Corporation · 2017 · cites it directly21descendants
- K233850Difiney Anti Snoring DeviceFissiontech, LLC · 2024 · 2 generations on3descendants
- K191618SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019 · 2 generations on3descendants
- K200657SmartGuard Anti-Snoring DeviceSmartguard Rx, Inc. · 2021 · 2 generations on2descendants
- K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte., Ltd. · 2026 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | 2007 | — |
| −3 | K100545 | Sleepright | Power Products, Inc.-Splintek | 2010 | — |
| −2 | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| −1 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| 0 (this device) | K153200 | SnoreRx | Apnea Sciences Corporation | 2016 | — |
| +1 | K170825 | SnoreRx | Apnea Sciences Corporation | 2017 | — |
| +2 | K233850 | Difiney Anti Snoring Device | Fissiontech, LLC | 2024 | — |
| +2 | K191618 | SleepTight Mouthpiece STZ | Michael D Williams Dds PA | 2019 | — |
| +2 | K200657 | SmartGuard Anti-Snoring Device | Smartguard Rx, Inc. | 2021 | — |
| +2 | K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K112205 | Snorerx 9.0Summary page 4…Product Code: LRK Regulation No. 21 CFR 872.5570 Predicate Device: SnoreRx NS 9.0 (Consumer Health Products, Inc.) Predicate 510(k) #: K112205 Device Description: The SnoreRx is an intraoral device that repositions the jaw anteriorly in orde… | 2011 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170825 | SnoreRx | 2017 | 21 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K170825 (Apnea Sciences Corporation, 2017) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K112205.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153200 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153200: SnoreRx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153200
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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