510(k) · Cleared
ClearedSicat Optisleep
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sicat GmbH & Co. KG · LRK Device, Anti-Snoring
Cleared on Mar 31, 2016 as substantially equivalent to K113201 (Resmed Sas, 2011) and 1 other predicate after a 139-day review. Its family tree reaches back 5 generations to 1989. 3 later devices descend from it.
- Decided
- Mar 31, 2016
- Review
- 139 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K882303 (1989). 9 ancestors in all, the oldest K880956 (1988). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 4 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 3 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 2 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 1 generation backK113201 Narval CCResmed Sas · 2011
- This deviceK153291 Sicat OptisleepSicat GmbH & Co. KG · 2016
- Descendant · cites it directly · 1 of its ownK182661 Kava and Kava with HerbstSketchpad Innovations, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK221889 ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep…Prosomnus Sleep Technologies · 2022
- Descendant · cites it directly · 0 of its ownK170053 Meridian PMThe Center For Craniofacial & Dental Sleep Medicine · 2017
Most influential descendants
Showing 3 of 3 · See all- K182661Kava and Kava with HerbstSketchpad Innovations, LLC · 2019 · cites it directly1descendant
- K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device…Prosomnus Sleep Technologies · 2022 · 2 generations on0descendants
- K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −4 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −3 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −2 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −1 | K113201 | Narval CC | Resmed Sas | 2011 | — |
| 0 (this device) | K153291 | Sicat Optisleep | Sicat GmbH & Co. KG | 2016 | — |
| +1 | K182661 | Kava and Kava with Herbst | Sketchpad Innovations, LLC | 2019 | — |
| +2 | K221889 | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore… | Prosomnus Sleep Technologies | 2022 | — |
| +1 | K170053 | Meridian PM | The Center For Craniofacial & Dental Sleep Medicine | 2017 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K113201 | Narval CCSummary page 4…Product Code: LRK Secondary Product Code: LQZ 3. PREDICATE DEVICES Primary Predicate: Narval CC (K113201) Reference Predicate: SomnoDent Classic (K050592) 4. DEVICE DESCRIPTION SICAT OPTISLEEP is a pure hardware… | 2011 |
| * | K050592 | Somnomed Mas RxaSummary page 4…de: LQZ 3. PREDICATE DEVICES Primary Predicate: Narval CC (K113201) Reference Predicate: SomnoDent Classic (K050592) 4. DEVICE DESCRIPTION SICAT OPTISLEEP is a pure hardware device. It is an oral appliance and will be manufactured by the SICAT… | 2005 |
What descends from it? (3)
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 27 years and passes through 6 companies; a new generation was cleared every 6.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K182661 (Sketchpad Innovations, LLC, 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K113201.
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?
In adult population
• To reduce or alleviate snoring
• To reduce or alleviate mild to moderate obstructive sleep apnea (OSA)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153291 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153291: Sicat Optisleep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153291
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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