510(k) · Cleared
ClearedTherasom-Cast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Family Dental Services, P.C. · LRK Device, Anti-Snoring
Cleared on Jan 4, 2013 as substantially equivalent to K971794 (Frantz Design, Inc., 1997) and 3 other predicates after a 402-day review. Its family tree reaches back 4 generations to 1989. 2 later devices descend from it.
- Decided
- Jan 4, 2013
- Review
- 402 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K882303 (1989). 10 ancestors in all, the oldest K880956 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 3 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 2 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 1 generation backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- This deviceK113516 Therasom-CastFamily Dental Services, P.C. · 2013
- Descendant · cites it directly · 0 of its ownK170053 Meridian PMThe Center For Craniofacial & Dental Sleep Medicine · 2017
- Descendant · cites it directly · 0 of its ownK150941 Somnowell Mandibular Advancement Appliance (MAA)Somnowell, Ltd. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −3 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −2 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −1 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| 0 (this device) | K113516 | Therasom-Cast | Family Dental Services, P.C. | 2013 | — |
| +1 | K170053 | Meridian PM | The Center For Craniofacial & Dental Sleep Medicine | 2017 | — |
| +1 | K150941 | Somnowell Mandibular Advancement Appliance (MAA) | Somnowell, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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? (4)
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 |
|---|---|---|---|
| * | K971794 | Elastic Mandibular Advancement (Ema) ApplianceSummary page 1…ence Product Number Code Myerson EMA Frantz Design, Inc. K971794 LRK Adjustable PM Positioner Jonathan A. Parker, D.D.S. K955503 LQZ Lowe Klearway… | 1997 |
| * | K955503 | Adjustable PM PositionerSummary page 1…Code Myerson EMA Frantz Design, Inc. K971794 LRK Adjustable PM Positioner Jonathan A. Parker, D.D.S. K955503 LQZ Lowe Klearway Dr. Alan A. Lowe, Inc. K950763 LRK SomnoMed MAS 16a… | 1996 |
| * | K950763 | Lowe KlearwaySummary page 1…LRK Adjustable PM Positioner Jonathan A. Parker, D.D.S. K955503 LQZ Lowe Klearway Dr. Alan A. Lowe, Inc. K950763 LRK SomnoMed MAS 16a SomnoMed, Ltd. K050592 LRK Intended Use:… | 1995 |
| * | K050592 | Somnomed Mas RxaSummary page 1…LQZ Lowe Klearway Dr. Alan A. Lowe, Inc. K950763 LRK SomnoMed MAS 16a SomnoMed, Ltd. K050592 LRK Intended Use: The TheraSom-CAST is used to reduce or alleviate the occurrence… | 2005 |
What descends from it? (2)
2 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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 7.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K170053 (The Center For Craniofacial & Dental Sleep Medicine, 2017) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K971794.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 TheraSom-CAST is used to reduce or alleviate the occurrence of snoring and/or for the treatment of mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113516: Therasom-Cast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113516
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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