510(k) · Cleared
ClearedEarlySense Insight Sytem
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 6, 2016 as substantially equivalent to K131379 (Earlysense, Ltd., 2013) and 2 other predicates after a 217-day review. Its family tree reaches back 9 generations to 1991. 5 later devices descend from it.
- Decided
- May 6, 2016
- Review
- 217 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910772 (1991). 53 ancestors in all, the oldest K830295 (1983). 5 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 5 generations between
- 3 generations backK040589 Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 2004
- 2 generations backK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
- 1 generation backK131379 EarlysenseEarlysense, Ltd. · 2013
- This deviceK152911 EarlySense Insight SytemEarlysense, Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK180079 Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor…Hill-Rom, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK202018 Hill-Rom Heart and Respiration Rate Monitoring System: Single…Hill-Rom, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK253274 BedDot (G1)Intelligent Dots, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK223246 Hillrom Heart and Respiration Rate Monitoring System powered by…Baxter Healthcare Corproration · 2022
- Descendant · cites it directly · 0 of its ownK171836 EarlySense Bed Sensing UnitEarlysense, Ltd. · 2018
Show all 9 generations
- Root · 9 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 8 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 4 generations backK031487 Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004
- 3 generations backK040589 Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 2004
- 2 generations backK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
- 1 generation backK131379 EarlysenseEarlysense, Ltd. · 2013
- This deviceK152911 EarlySense Insight SytemEarlysense, Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc. · 2018 · cites it directly2descendants
- K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc. · 2021 · 2 generations on1descendant
- K253274BedDot (G1)Intelligent Dots, LLC · 2026 · cites it directly0descendants
- K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration · 2022 · 3 generations on0descendants
- K171836EarlySense Bed Sensing UnitEarlysense, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −8 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −4 | K031487 | Model Avant 2120 Pulse Oximeter and Nibp | Nonin Medical, Inc. | 2004 | — |
| −3 | K040589 | Modification to Avant 9600 Pulse Oximeter | Nonin Medical, Inc. | 2004 | — |
| −2 | K120465 | Earlysense (Everon) System | Earlysense, Ltd. | 2012 | — |
| −1 | K131379 | Earlysense | Earlysense, Ltd. | 2013 | — |
| 0 (this device) | K152911 | EarlySense Insight Sytem | Earlysense, Ltd. | 2016 | — |
| +1 | K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs… | Hill-Rom, Inc. | 2018 | — |
| +2 | K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom… | Hill-Rom, Inc. | 2021 | — |
| +1 | K253274 | BedDot (G1) | Intelligent Dots, LLC | 2026 | — |
| +3 | K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | Baxter Healthcare Corproration | 2022 | — |
| +1 | K171836 | EarlySense Bed Sensing Unit | Earlysense, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K131379 | EarlysenseSummary page 4…ass: II Product Code: BZQ, There were no prior submissions for the subject device. III. DEVICES Primary Predicate: EarlySense 2.0 System (K131379) manufactured by EarlySense Ltd, which can be used both with under the mattress bed sensing unit and with Chair Sensing… | 2013 |
| * | K133661 | Chair Sensing Unit for Earlysense SystemSummary page 4…arlySense 2.0 System (K131379) manufactured by EarlySense Ltd, which can be used both with under the mattress bed sensing unit and with Chair Sensing Unit (K133661) Secondary Predicate: Wireless 2000 PAMTM3000 (K082626) manufactured by Wireless 2000 These predicates have… | 2014 |
| * | K082626 | PAM 3000Summary page 4…can be used both with under the mattress bed sensing unit and with Chair Sensing Unit (K133661) Secondary Predicate: Wireless 2000 PAMTM3000 (K082626) manufactured by Wireless 2000 These predicates have not been subjects to a design-related recall. Reference:… | 2009 |
| † | K024322 | Embla N7000 | 2003 |
What descends from it? (5)
3 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 25 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 53 ancestors have a recall of any class.
- Of its descendants, K180079 (Hill-Rom, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K131379.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 EarlySense InSight System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 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/K152911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152911: EarlySense Insight Sytem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152911
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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