510(k) · Cleared
ClearedEarlySense Bed Sensing Unit
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 Jan 4, 2018 as substantially equivalent to K131379 (Earlysense, Ltd., 2013) and 1 other predicate after a 198-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Jan 4, 2018
- Review
- 198 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K910772 (1991). 54 ancestors in all, the oldest K830295 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations between
- 3 generations backK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
- 2 generations backK131379 EarlysenseEarlysense, Ltd. · 2013
- 1 generation backK152911 EarlySense Insight SytemEarlysense, Ltd. · 2016
- This deviceK171836 EarlySense Bed Sensing UnitEarlysense, Ltd. · 2018
Show all 10 generations
- Root · 10 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 9 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 8 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 5 generations backK031487 Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004
- 4 generations backK040589 Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 2004
- 3 generations backK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
- 2 generations backK131379 EarlysenseEarlysense, Ltd. · 2013
- 1 generation backK152911 EarlySense Insight SytemEarlysense, Ltd. · 2016
- This deviceK171836 EarlySense Bed Sensing UnitEarlysense, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −9 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −8 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −5 | K031487 | Model Avant 2120 Pulse Oximeter and Nibp | Nonin Medical, Inc. | 2004 | — |
| −4 | K040589 | Modification to Avant 9600 Pulse Oximeter | Nonin Medical, Inc. | 2004 | — |
| −3 | K120465 | Earlysense (Everon) System | Earlysense, Ltd. | 2012 | — |
| −2 | K131379 | Earlysense | Earlysense, Ltd. | 2013 | — |
| −1 | K152911 | EarlySense Insight Sytem | Earlysense, Ltd. | 2016 | — |
| 0 (this device) | 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 |
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? (2)
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 5…Page 1 of 9 III. Predicate Devices: EarlySense Bed Sensing unit cleared as component to EarlySense 2.0 System (K131379) and EarlySense Bed Sensing unit cleared as component to EarlySense InSight System (K152911). A Traditional 510(k) is submitted… | 2013 |
| * | K152911 | EarlySense Insight SytemSummary page 5…EarlySense Bed Sensing unit cleared as component to EarlySense 2.0 System (K131379) and EarlySense Bed Sensing unit cleared as component to EarlySense InSight System (K152911). A Traditional 510(k) is submitted for the modifications made to the cleared EarlySense Bed Sensing Unit. IV. Devic… | 2016 |
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 27 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 54 ancestors have a recall of any class.
- 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. 2018, 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 Bed Sensing Unit is an accessory that is compatible with bedside units of EarlySense Systems (Models 2.0 and InSight) intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner. Environment of use for the accessory is defined as per compatible cleared bedside units labeling: EarlySense 2.0 - at home, in hospital or clinic setting and InSight - in hospital or clinic setting. The device is indicated for use in children, adolescents and adults. The operation of the EarlySense system 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/K171836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171836: EarlySense Bed Sensing Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171836
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