510(k) · Cleared
ClearedRespironics Custom I Oral Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · LRK Device, Anti-Snoring
Cleared on Feb 6, 2004 as substantially equivalent to K954530 (Silent Knights Ventures, Inc., 1995) after a 58-day review. Its family tree reaches back 1 generation to 1995. 35 later devices descend from it.
- Decided
- Feb 6, 2004
- Review
- 58 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954530 (1995). 35 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK954530 The SilencerSilent Knights Ventures, Inc. · 1995
- This deviceK033822 Respironics Custom I Oral ApplianceRespironics, Inc. · 2004
- Descendant · cites it directly · 22 of its ownK061688 Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH · 2006
- Descendant · 2 generations on · 10 of its ownK090503 Zquiet MouthpieceSleeping Well, LLC · 2009
- Descendant · 3 generations on · 8 of its ownK093407 Zquiet MouthpieceSleeping Well, LLC · 2010
- Descendant · 4 generations on · 6 of its ownK180124 ZQuietSleeping Well, LLC · 2018
- Descendant · 2 generations on · 6 of its ownK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K061688Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH · 2006 · cites it directly22descendants
- K090503Zquiet MouthpieceSleeping Well, LLC · 2009 · 2 generations on10descendants
- K093407Zquiet MouthpieceSleeping Well, LLC · 2010 · 3 generations on8descendants
- K180124ZQuietSleeping Well, LLC · 2018 · 4 generations on6descendants
- K111680DR. Greensburg's HybridAlways More Marketing, Inc. · 2011 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954530 | The Silencer | Silent Knights Ventures, Inc. | 1995 | — |
| 0 (this device) | K033822 | Respironics Custom I Oral Appliance | Respironics, Inc. | 2004 | — |
| +1 | K061688 | Anti-Snoring / Sleep Apnea Device | Tomed Dr. Toussaint GmbH | 2006 | — |
| +2 | K090503 | Zquiet Mouthpiece | Sleeping Well, LLC | 2009 | — |
| +3 | K093407 | Zquiet Mouthpiece | Sleeping Well, LLC | 2010 | — |
| +4 | K180124 | ZQuiet | Sleeping Well, LLC | 2018 | — |
| +2 | K111680 | DR. Greensburg's Hybrid | Always More Marketing, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 7 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K954530 | The SilencerSummary page 1…Oral Appliance Proprietary Name Respironics Custom I Oral Appliance Predicate Device(s) Respironics Silencer (K954530) Reason for submission Modified design. ©2003 Respironics Inc. Tab 3 Res, onics Halstrom… | 1995 |
What descends from it? (35)
See all 354 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?
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?
The Respironics Custom I Oral Appliance is intended for use by a dentist on adult patients as an aid for the reduction or elimination of snoring and obstructive sleep apnea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033822: Respironics Custom I Oral Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033822
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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