510(k) · Cleared
ClearedRemotely Controlled Mandibular Positioner, RCMP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zephyr Sleep Technologies, Inc. · LRK Device, Anti-Snoring
Cleared on Mar 23, 2012 as substantially equivalent to K973884 (Frantz Design, Inc., 1998) and 2 other predicates after a 459-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Mar 23, 2012
- Review
- 459 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K882303 (1989). 18 ancestors in all, the oldest K880956 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 6 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 5 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 4 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 3 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 2 generations backK062951 Tap Iii Anti-Snoring DeviceAirway Management, Inc. · 2006
- 1 generation backK111110 Apnea GuardAdvanced Brain Monitoring, Inc. · 2011
- This deviceK103704 Remotely Controlled Mandibular Positioner, RCMPZephyr Sleep Technologies, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −7 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −6 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −5 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −4 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −3 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −2 | K062951 | Tap Iii Anti-Snoring Device | Airway Management, Inc. | 2006 | — |
| −1 | K111110 | Apnea Guard | Advanced Brain Monitoring, Inc. | 2011 | — |
| 0 (this device) | K103704 | Remotely Controlled Mandibular Positioner, RCMP | Zephyr Sleep Technologies, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K973884 | Elastic Mandibular Advancement - Titration (Ema-T) AppilanceSummary page 3…is substantially equivalent to the The Remote Controlled Mandibular Positioner (RCMP), EMA-T, (K-973884) manufactured Elastic Mandibular Advancement Titration appliance, intended… | 1998 |
| * | K043330 | Polypropilene Surgical SuturesSummary page 1…ain technology. is claimed to the DemeTECH Polypropylene Surgical Sutures Substantial equivalence material. (K043330) for the patient contacting is claimed to the Apnea Guard (KI 11110) for the cleaning Su… | 2005 |
| * | K111110 | Apnea Guard Cleared while this submission was under review | 2011 |
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 23 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- None of the 18 ancestors has a recall.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Overnight use of a temporary oral appliance to determine in which patients with obstructive sleep apnea mandibular advancement by an oral appliance will reduce obstruction of airflow and thereby to identify patients suitable for oral appliance therapy. The device is also used to recommend a target mandibular position that will reduce obstruction of airflow in patients determined to be suitable for oral appliance therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103704: Remotely Controlled Mandibular Positioner, RCMP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103704
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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