510(k) · Cleared
ClearedEarlysense ES-16 System
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 Nov 15, 2007 as substantially equivalent to K024322 (Medcare Flaga, 2003) and 2 other predicates after a 280-day review. Its family tree reaches back 2 generations to 1983. 23 later devices descend from it.
- Decided
- Nov 15, 2007
- Review
- 280 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K830295 (1983). 14 ancestors in all. 23 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 1 generation backK971813 EMBLAFerguson Medical · 1998
- This deviceK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007
- Descendant · cites it directly · 21 of its ownK082626 PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009
- Descendant · cites it directly · 11 of its ownK082465 EveronEarlysense, Ltd. · 2009
- Descendant · 2 generations on · 10 of its ownK092062 Everon 1.0Earlysense, Ltd. · 2010
- Descendant · 2 generations on · 9 of its ownK202464 Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021
- Descendant · 3 generations on · 9 of its ownK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K082626PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009 · cites it directly21descendants
- K082465EveronEarlysense, Ltd. · 2009 · cites it directly11descendants
- K092062Everon 1.0Earlysense, Ltd. · 2010 · 2 generations on10descendants
- K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021 · 2 generations on9descendants
- K120465Earlysense (Everon) SystemEarlysense, Ltd. · 2012 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −1 | K971813 | EMBLA | Ferguson Medical | 1998 | — |
| 0 (this device) | K070375 | Earlysense ES-16 System | Earlysense, Ltd. | 2007 | — |
| +1 | K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies, Ltd. | 2009 | — |
| +1 | K082465 | Everon | Earlysense, Ltd. | 2009 | — |
| +2 | K092062 | Everon 1.0 | Earlysense, Ltd. | 2010 | — |
| +2 | K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021 | — |
| +3 | K120465 | Earlysense (Everon) System | Earlysense, Ltd. | 2012 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K024322 | Embla N7000Summary page 2…devices and a standard procedure for the EarlySense'T M ES-16 System substantial equivalence discussion: * Embla N7000 [Embla Systems, Inc.] cleared under K024322 (breathing frequency monitor, Class II-MNR); hereinafter: Embla System, supplemented with Somnologica Studio Soft… | 2003 |
| * | K971813 | EMBLASummary page 2…monitor, Class II-MNR); hereinafter: Embla System, supplemented with Somnologica Studio Software [Ferguson Medical] cleared as part of Embla System under K971813 (Electroencephalograph, Class II-GWQ) * LifeShirt System with VivoLogic Analysis Software [VivoMetrics Inc… | 1998 |
| * | K011903 | Lifeshirt System with Vivologic Analysis SoftwareSummary page 2…la System under K971813 (Electroencephalograph, Class II-GWQ) * LifeShirt System with VivoLogic Analysis Software [VivoMetrics Inc.] cleared under K011903 (programmable diagnostic computer, Class II-DQK) 5.8 Device Description: The EarlySense TM ES-16 System c… | 2002 |
What descends from it? (23)
See all 232 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K082626 (Wireless 2000 RF & Uwb Technologies, Ltd., 2009) has gone furthest, with 21 descendants of its own.
- 4 other devices also cite its predicate K024322.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 EarlySenseTM 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 ES-16 System has been studied in children (weight Ž>10 Kg) and adults (weight <111 Kg) during sleep and resting condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070375: Earlysense ES-16 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070375
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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