510(k) · Cleared
ClearedElastic Mandibular Advancement - Titration (Ema-T) Appilance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Frantz Design, Inc. · LRK Device, Anti-Snoring
Cleared on Jan 9, 1998 as substantially equivalent to K971794 (Frantz Design, Inc., 1997) after an 87-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Jan 9, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K880956 (1988). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK880956 Snoar (TM) Open Airway ApplianceKent J. Toone, D.D.S. · 1988
- 1 generation backK971794 Elastic Mandibular Advancement (Ema) ApplianceFrantz Design, Inc. · 1997
- This deviceK973884 Elastic Mandibular Advancement - Titration (Ema-T) AppilanceFrantz Design, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK103704 Remotely Controlled Mandibular Positioner, RCMPZephyr Sleep Technologies, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K103704Remotely Controlled Mandibular Positioner, RCMPZephyr Sleep Technologies, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880956 | Snoar (TM) Open Airway Appliance | Kent J. Toone, D.D.S. | 1988 | — |
| −1 | K971794 | Elastic Mandibular Advancement (Ema) Appliance | Frantz Design, Inc. | 1997 | — |
| 0 (this device) | K973884 | Elastic Mandibular Advancement - Titration (Ema-T) Appilance | Frantz Design, Inc. | 1998 | — |
| +1 | K103704 | Remotely Controlled Mandibular Positioner, RCMP | Zephyr Sleep Technologies, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K971794 | Elastic Mandibular Advancement (Ema) ApplianceSummary page 1…e Comparison: The Elastic Mandibular Advancement Titration (EMA-T) appliance is substantially equivalent to the Elastic Mandibular Advancement (EMA) appliance [510(k) # K 971794]. Description: Currently, there is no method to predict which patients will respond to treatment of obstructive sleep apnea (OS… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103704 | Remotely Controlled Mandibular Positioner, RCMP | 2012 | 0 |
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 10 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103704 (Zephyr Sleep Technologies, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K971794.
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?
Temporary treatment of obstructive sleep apnea and snoring to determine in which patients mandibular advancement and opening the bite will increase the patients air space
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/K973884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973884: Elastic Mandibular Advancement - Titration (Ema-T) Appilance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973884
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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