510(k) · Cleared
ClearediNOS intraoral biosensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Achaemenid, LLC · PLC Sleep Appliances With Patient Monitoring
Cleared on Aug 25, 2026 as substantially equivalent to K230532 (Achaemenid, LLC, 2023) and 1 other predicate after a 237-day review. Its family tree reaches back 12 generations to 1989.
- Decided
- Aug 25, 2026
- Review
- 237 days
- Class
- Class II
- Product code
- PLC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K882303 (1989). 29 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 8 generations between
- 3 generations backK192581 The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020
- 2 generations backK191320 Slow Wave DS8Slow Wave, Inc. · 2020
- 1 generation backK230532 RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC · 2023
- This deviceK254304 iNOS intraoral biosensorAchaemenid, LLC · 2026
Show all 12 generations
- Root · 12 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 11 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 10 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 9 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 8 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 7 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 6 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 5 generations backK103076 DynaflexDyna Flex · 2011
- 4 generations backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- 3 generations backK192581 The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020
- 2 generations backK191320 Slow Wave DS8Slow Wave, Inc. · 2020
- 1 generation backK230532 RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC · 2023
- This deviceK254304 iNOS intraoral biosensorAchaemenid, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −11 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −10 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −9 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −8 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −7 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −6 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −5 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| −4 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| −3 | K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | 2020 | — |
| −2 | K191320 | Slow Wave DS8 | Slow Wave, Inc. | 2020 | — |
| −1 | K230532 | RADx Intraoral Appliance for Snoring and Sleep Apnea | Achaemenid, LLC | 2023 | — |
| 0 (this device) | K254304 | iNOS intraoral biosensor | Achaemenid, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 PLC? 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 PLC device
- #1 K252765 ProSomnus RPMO2 OSA Device (RPMO2 OSA)score 17.1 · 11 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 |
|---|---|---|---|
| * | K230532 | RADx Intraoral Appliance for Snoring and Sleep ApneaSummary page 5…dary Product Codes: DQA, LQZ, LRK, OUG 3. PREDICATE DEVICES Primary Predicate Device – Achaemenid – RADx Intraoral Appliance – K230532 Secondary Predicate Device – ProSomnus RPMO2 OSA Device – K252765 4. DEVICE DESCRIPTION The iNOS Intraor… | 2023 |
| * | K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) Cleared while this submission was under review Summary page 5…Primary Predicate Device – Achaemenid – RADx Intraoral Appliance – K230532 Secondary Predicate Device – ProSomnus RPMO2 OSA Device – K252765 4. DEVICE DESCRIPTION The iNOS Intraoral Biosensor is a medical grade oximeter hermetically sealed inside an upper… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 11 companies; a new generation was cleared every 2.8 years on median.
- None of the 29 ancestors has a recall.
How does its category compare?
All PLC devicesPLC Sleep Appliances With Patient Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PLC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PLC
Too few PLC 510(k)s in any year since 2007 to give a median.
Recalls per year · PLC
No recall names PLC since 2007.
Adverse event reports per year · PLC
1in 2023
MAUDE reports naming product code PLC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The iNOS intraoral biosensor is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Additionally, the fully embedded oximeter sensor measures, displays, stores and transmits functional oxygen saturation of the arterial hemoglobin (SpO2). It is intended for continuous data collection during sleep. It can be used in sleep labs, long term care, hospitals and home use.
The device is intended to be applied in the oral cavity. The device is intended for use under non-motion conditions in well perfused areas. The device is single patient, reusable.
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/K254304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254304: iNOS intraoral biosensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254304
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026