510(k) · Cleared
ClearedHill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom, Inc. · BZQ Monitor, Breathing Frequency
Cleared on Mar 4, 2021 as substantially equivalent to K180079 (Hill-Rom, Inc., 2018) after a 226-day review. Its family tree reaches back 11 generations to 1991. 1 later device descends from it.
- Decided
- Mar 4, 2021
- Review
- 226 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K910772 (1991). 55 ancestors in all, the oldest K830295 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 7 generations between
- 3 generations backK131379 EarlysenseEarlysense, Ltd. · 2013
- 2 generations backK152911 EarlySense Insight SytemEarlysense, Ltd. · 2016
- 1 generation backK180079 Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor…Hill-Rom, Inc. · 2018
- This deviceK202018 Hill-Rom Heart and Respiration Rate Monitoring System: Single…Hill-Rom, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK223246 Hillrom Heart and Respiration Rate Monitoring System powered by…Baxter Healthcare Corproration · 2022
Show all 11 generations
- Root · 11 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 10 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 9 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 8 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 6 generations backK031487 Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004
- 5 generations backK040589 Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 2004
- 4 generations backK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
- 3 generations backK131379 EarlysenseEarlysense, Ltd. · 2013
- 2 generations backK152911 EarlySense Insight SytemEarlysense, Ltd. · 2016
- 1 generation backK180079 Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor…Hill-Rom, Inc. · 2018
- This deviceK202018 Hill-Rom Heart and Respiration Rate Monitoring System: Single…Hill-Rom, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −10 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −9 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −8 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −6 | K031487 | Model Avant 2120 Pulse Oximeter and Nibp | Nonin Medical, Inc. | 2004 | — |
| −5 | K040589 | Modification to Avant 9600 Pulse Oximeter | Nonin Medical, Inc. | 2004 | — |
| −4 | K120465 | Earlysense (Everon) System | Earlysense, Ltd. | 2012 | — |
| −3 | K131379 | Earlysense | Earlysense, Ltd. | 2013 | — |
| −2 | K152911 | EarlySense Insight Sytem | Earlysense, Ltd. | 2016 | — |
| −1 | K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs… | Hill-Rom, Inc. | 2018 | — |
| 0 (this device) | K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom… | Hill-Rom, Inc. | 2021 | — |
| +1 | K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | Baxter Healthcare Corproration | 2022 | — |
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 |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Summary page 4…Breathing Frequency Monitor (21 CFR 868.2375) Regulatory Class: II Product Code: BZQ III. PREDICATE DEVICE Hill-Rom® Vitals Monitoring System powered by EarlySense® (K180079) IV. DEVICE DESCRIPTION The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense is designed for contin… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | 2022 | 0 |
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 30 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 55 ancestors have a recall of any class.
- Of its descendants, K223246 (Baxter Healthcare Corproration, 2022) has gone furthest, with 0 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. 2021, 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 Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense is used with compatible bed system models and is intended for continuous measurement of respiration rate (RR) and heart rate (HR) in an automatic, contact-less manner. The system is indicated for use in children, adolescents, and adults in hospitals or clinical settings. It is intended to be used for the same patient populations and the same settings, within these ranges, as the bed with which it is used. The system has been validated to withstand up to 700 1b (318 kg).
NOTE: Do not exceed the limit of the bed system for weight, population, or use setting.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202018: Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202018
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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