510(k) · Cleared
ClearedTap 3, Tap 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airway Management, Inc. · PLC Sleep Appliances With Patient Monitoring
Cleared on Aug 10, 2016 as substantially equivalent to K150369 (Somnomed, Inc., 2015) after a 191-day review. Its family tree reaches back 9 generations to 1989.
- Decided
- Aug 10, 2016
- Review
- 191 days
- Class
- Class II
- Product code
- PLC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K882303 (1989). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations between
- 3 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 2 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 1 generation backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- This deviceK160239 Tap 3, Tap 1Airway Management, Inc. · 2016
Show all 9 generations
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 8 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 7 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 6 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 5 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
- 4 generations backK121340 Somnodent G2Somnomed, Inc. · 2012
- 3 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 2 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 1 generation backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- This deviceK160239 Tap 3, Tap 1Airway Management, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −8 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −7 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −6 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −5 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| −4 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| −3 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| −2 | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | Somnomed, Inc. | 2014 | — |
| −1 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac… | Somnomed, Inc. | 2015 | — |
| 0 (this device) | K160239 | Tap 3, Tap 1 | Airway Management, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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? (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 |
|---|---|---|---|
| * | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…Summary page 4…PLC Class / CFR: Class II, 21CFR 872.5570 Device: TAP® 1 and TAP® 3 Predicate Device: K150369 - SomnoMed SomnoDent® with micro-recorder Reference Devices: K062951… | 2015 |
| † | K062951 | Tap Iii Anti-Snoring Device | 2006 |
| † | K964516 | TAP | 1997 |
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 27 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- None of the 10 ancestors has a recall.
- 4 other devices also cite its predicate K150369.
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. 2016, 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 TAP(r) family of intra-oral appliances are intended for the treatment of night-time snoring and mild to moderate
obstructive sleep apnea in patients 18 years or age or older.
The DentiTrac(r) micro-recorder is completely embedded into the TAP(r) intra-oral appliance, the micro-recorder is
intended to measure patient compliance to oral device / appliance therapy when used in combination with the DentiTrac(r)
System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160239: Tap 3, Tap 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160239
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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