510(k) · Cleared
ClearedBluePro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bluesom · LRK Device, Anti-Snoring
Cleared on Dec 15, 2016 as substantially equivalent to K113569 (Apnea Science Corporation, 2012) after a 133-day review. Its family tree reaches back 5 generations to 2007.
- Decided
- Dec 15, 2016
- Review
- 133 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K071404 (2007). 13 ancestors in all, the oldest K882303 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- 4 generations backK100545 SleeprightPower Products, Inc.-Splintek · 2010
- 3 generations backK103004 Snore GuardRanir, LLC · 2011
- 2 generations backK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- 1 generation backK113569 ApnearxApnea Science Corporation · 2012
- This deviceK162192 BlueProBluesom · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | 2007 | — |
| −4 | K100545 | Sleepright | Power Products, Inc.-Splintek | 2010 | — |
| −3 | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| −2 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| −1 | K113569 | Apnearx | Apnea Science Corporation | 2012 | — |
| 0 (this device) | K162192 | BluePro | Bluesom | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K113569 | ApnearxSummary page 4…and intraoral devices for snoring and obstructive sleep apnea 21 CFR 872.5570, Class 2 Predicate Device: K113569 – Apnea Sciences – ApneaRx Device Description The BluePro® oral appliance design concept is based upon the use of a standard set… | 2012 |
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 9 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- None of the 13 ancestors has a recall.
- 2 other devices also cite its predicate K113569.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The BluePro® is a mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162192: BluePro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162192
Report an extraction error
Are you the manufacturer?
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