510(k) · Cleared
ClearedThe Suad Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Strong Dental, Inc. · LRK Device, Anti-Snoring
Cleared on Jul 8, 2003 as substantially equivalent to K955822 (Univ. Dental Assoc. Department of Orthodontics, 1996) after a 232-day review. Its family tree reaches back 1 generation to 1996. 11 later devices descend from it.
- Decided
- Jul 8, 2003
- Review
- 232 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955822 (1996). 11 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK955822 Removable Herbst ApplianceUniv. Dental Assoc. Department of Orthodontics · 1996
- This deviceK023836 The Suad DeviceStrong Dental, Inc. · 2003
- Descendant · cites it directly · 7 of its ownK131138 Respire Pink Series - HerbstRespire Medical · 2013
- Descendant · 2 generations on · 5 of its ownK150572 Respire Pink Series-Herbst-EFRespire Medical Holding · 2015 · Recalled
- Descendant · 2 generations on · 2 of its ownK170692 Respire Pink Series with DentiTracRespire Medical Holding · 2017
- Descendant · 3 generations on · 1 of its ownK192127 Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings · 2020
- Descendant · 2 generations on · 0 of its ownK223624 Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K131138Respire Pink Series - HerbstRespire Medical · 2013 · cites it directly7descendants
- K150572Respire Pink Series-Herbst-EFRespire Medical Holding · 2015 · 2 generations on5descendants
- K170692Respire Pink Series with DentiTracRespire Medical Holding · 2017 · 2 generations on2descendants
- K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings · 2020 · 3 generations on1descendant
- K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955822 | Removable Herbst Appliance | Univ. Dental Assoc. Department of Orthodontics | 1996 | — |
| 0 (this device) | K023836 | The Suad Device | Strong Dental, Inc. | 2003 | — |
| +1 | K131138 | Respire Pink Series - Herbst | Respire Medical | 2013 | — |
| +2 | K150572 | Respire Pink Series-Herbst-EF | Respire Medical Holding | 2015 | 3 |
| +2 | K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | 2017 | — |
| +3 | K192127 | Respire Pink AT (Hard, Hard/Soft, EF) | Respire Medical Holdings | 2020 | — |
| +2 | K223624 | Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K955822 | Removable Herbst ApplianceSummary page 1…le Herbst Appliance is the predicate device for the SUAD'" Device, having all the same functional characteristics, The Removable Herbst Appliance (510(k) K955822)is a custom-fitted mandibular device that allows patienrs to move their jaw laterally and vertically without disengaging… | 1996 |
What descends from it? (11)
See all 114 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?
- Its one ancestor has no recall.
- Of its descendants, K131138 (Respire Medical, 2013) has gone furthest, with 7 descendants 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.
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?
A custom-fitted mandibular repositioning device intended to reduce or alleviate
nighttime snoring and obstructive sleep apnea.
Contraindications:
The device is contraindicated for patients who:
Have central sleep apnea
Have severe respiratory disorders
Have an edentulous arch
Have loose teeth or advanced periodontal disease
Are under 18 years of age.
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/K023836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023836: The Suad Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023836
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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