510(k) · Cleared
ClearedEveron
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Earlysense, Ltd. · BZQ Monitor, Breathing Frequency
Cleared on Mar 25, 2009 as substantially equivalent to K070375 (Earlysense, Ltd., 2007) after a 210-day review. Its family tree reaches back 3 generations to 1983. 11 later devices descend from it.
- Decided
- Mar 25, 2009
- Review
- 210 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K830295 (1983). 15 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 2 generations backK971813 EMBLAFerguson Medical · 1998
- 1 generation backK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007
- This deviceK082465 EveronEarlysense, Ltd. · 2009
- Descendant · cites it directly · 10 of its ownK092062 Everon 1.0Earlysense, Ltd. · 2010
- Descendant · 2 generations on · 9 of its ownK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
- Descendant · 3 generations on · 7 of its ownK131379 EarlysenseEarlysense, Ltd. · 2013
- Descendant · 3 generations on · 6 of its ownK133661 Chair Sensing Unit for Earlysense SystemEarlysense, Ltd. · 2014
- Descendant · 4 generations on · 5 of its ownK152911 EarlySense Insight SytemEarlysense, Ltd. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K092062Everon 1.0Earlysense, Ltd. · 2010 · cites it directly10descendants
- K120465Earlysense (Everon) SystemEarlysense, Ltd. · 2012 · 2 generations on9descendants
- K131379EarlysenseEarlysense, Ltd. · 2013 · 3 generations on7descendants
- K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd. · 2014 · 3 generations on6descendants
- K152911EarlySense Insight SytemEarlysense, Ltd. · 2016 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −2 | K971813 | EMBLA | Ferguson Medical | 1998 | — |
| −1 | K070375 | Earlysense ES-16 System | Earlysense, Ltd. | 2007 | — |
| 0 (this device) | K082465 | Everon | Earlysense, Ltd. | 2009 | — |
| +1 | K092062 | Everon 1.0 | Earlysense, Ltd. | 2010 | — |
| +2 | K120465 | Earlysense (Everon) System | Earlysense, Ltd. | 2012 | — |
| +3 | K131379 | Earlysense | Earlysense, Ltd. | 2013 | — |
| +3 | K133661 | Chair Sensing Unit for Earlysense System | Earlysense, Ltd. | 2014 | — |
| +4 | K152911 | EarlySense Insight Sytem | Earlysense, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 BZQ? 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 BZQ device
- #1 K251326 Respiration Rate algorithmscore 20.2 · 30 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 |
|---|---|---|---|
| * | K070375 | Earlysense ES-16 SystemSummary page 1…Class II; Product Code- BZQ 7.1.7 Predicate Devices The ES-16 System, cleared under K070375. 7-1 7.1.8 Device Description: The modified EarlySense T M EverOn Syste… | 2007 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092062 | Everon 1.0 | 2010 | 10 |
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 26 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K092062 (Earlysense, Ltd., 2010) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K070375.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BZQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZQ
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZQ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZQ
2in 2022
MAUDE reports naming product code BZQ, 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 | 2 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 121 | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 3 | 261 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 3 | 198 | 0 | 10 |
| 2019 | 1 | — | 0 | 13 |
| 2020 | 2 | — | 0 | 10 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 198 | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 7 | 255 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The EverOn (modified EarlySense TM ES-16) system is intended for continuous measurement of respiration rate and heart rate, in an automatic contact-less manner, at home, hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EverOn has been studied in children (weight Ž10 Kg) and adults (weight _111 Kg) during sleep and resting condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082465: Everon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082465
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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