510(k) · Cleared
ClearedEveron 1.0
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 May 24, 2010 as substantially equivalent to K082465 (Earlysense, Ltd., 2009) and 2 other predicates after a 320-day review. Its family tree reaches back 5 generations to 1992. 10 later devices descend from it.
- Decided
- May 24, 2010
- Review
- 320 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K913396 (1992). 28 ancestors in all, the oldest K830295 (1983). 10 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 4 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 3 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 2 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 1 generation backK041904 Compass F10 SystemMedcare Flaga · 2004
- This deviceK092062 Everon 1.0Earlysense, Ltd. · 2010
- Descendant · cites it directly · 9 of its ownK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
- Descendant · 2 generations on · 7 of its ownK131379 EarlysenseEarlysense, Ltd. · 2013
- Descendant · 2 generations on · 6 of its ownK133661 Chair Sensing Unit for Earlysense SystemEarlysense, Ltd. · 2014
- Descendant · 3 generations on · 5 of its ownK152911 EarlySense Insight SytemEarlysense, Ltd. · 2016
- Descendant · 4 generations on · 2 of its ownK180079 Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor…Hill-Rom, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K120465Earlysense (Everon) SystemEarlysense, Ltd. · 2012 · cites it directly9descendants
- K131379EarlysenseEarlysense, Ltd. · 2013 · 2 generations on7descendants
- K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd. · 2014 · 2 generations on6descendants
- K152911EarlySense Insight SytemEarlysense, Ltd. · 2016 · 3 generations on5descendants
- K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc. · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −4 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −3 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −2 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −1 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| 0 (this device) | K092062 | Everon 1.0 | Earlysense, Ltd. | 2010 | — |
| +1 | K120465 | Earlysense (Everon) System | Earlysense, Ltd. | 2012 | — |
| +2 | K131379 | Earlysense | Earlysense, Ltd. | 2013 | — |
| +2 | K133661 | Chair Sensing Unit for Earlysense System | Earlysense, Ltd. | 2014 | — |
| +3 | K152911 | EarlySense Insight Sytem | Earlysense, Ltd. | 2016 | — |
| +4 | K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs… | Hill-Rom, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K082465 | EveronSummary page 1…ng on the combination of the following predicate devices for the EverOn's movement capability substantial equivalence discussion. The EverOn System, cleared under K082465, breathing frequency - 868.2375, Class II; Product Code- BZQ 7-2… | 2009 |
| * | K041904 | Compass F10 SystemSummary page 2…frequency - 868.2375, Class II; Product Code- BZQ 7-2 * Compass FlO0 system ( MedCare) cleared under K04 1904 (Ventilatory Effort Recorder, Class II - Regulation number 866.2375- MNR) * PAM 3000 (Wireless 2000 RIF & UWB Techno… | 2004 |
| * | K082626 | PAM 3000Summary page 2…1904 (Ventilatory Effort Recorder, Class II - Regulation number 866.2375- MNR) * PAM 3000 (Wireless 2000 RIF & UWB Technologies Ltd) cleared under K(082626 - Heart Rate and Respiration rate monitor (monitor, cardiac (incl. cardiotachometer & rate alarm monitor, breathing freque… | 2009 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120465 | Earlysense (Everon) System | 2012 | 9 |
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 18 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K120465 (Earlysense, Ltd., 2012) has gone furthest, with 9 descendants of its own.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 1.0 system is intended for continuous measurement of
respiration rate, heart rate and movement, 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 Ž10Kg) and adults (weight <111 Kg) during sleep
and resting condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092062 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092062: Everon 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092062
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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