510(k) · Cleared
ClearedSleepminder Breathing Frequency Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biancamed Limited · BZQ Monitor, Breathing Frequency
Cleared on Jul 21, 2011 as substantially equivalent to K090273 (Kai Sensors, Inc., 2009) and 1 other predicate after a 220-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.
- Decided
- Jul 21, 2011
- Review
- 220 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913396 (1992). 51 ancestors in all, the oldest K830295 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 6 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 5 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 4 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 3 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 2 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 1 generation backK090273 Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai…Kai Sensors, Inc. · 2009
- This deviceK103631 Sleepminder Breathing Frequency IndicatorBiancamed Limited · 2011
- Descendant · cites it directly · 0 of its ownK200445 The C100 Contactless Breathing MonitorCircadia Technologies, Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −6 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −5 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −4 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −3 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −2 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −1 | K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot… | Kai Sensors, Inc. | 2009 | — |
| 0 (this device) | K103631 | Sleepminder Breathing Frequency Indicator | Biancamed Limited | 2011 | — |
| +1 | K200445 | The C100 Contactless Breathing Monitor | Circadia Technologies, Ltd. | 2020 | — |
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 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Summary page 1…Class II, Breathing Frequency Monitor, 21.CFR.868.2375 , Product code BZQ Predicate Devices * Kai Sensors Kai R-Spot 100, Breathing Frequency Monitor, [K090273]. * Somnomedics SOMNOscreen Plus RC Easy, Ventilatory Effort Recorder, [K060708]… | 2009 |
| * | K060708 | SomnoscreenSummary page 1…* Kai Sensors Kai R-Spot 100, Breathing Frequency Monitor, [K090273]. * Somnomedics SOMNOscreen Plus RC Easy, Ventilatory Effort Recorder, [K060708] Page 15 of 67 5lO&,S-BMO7-AI-I 10503-PP Intended Use / Indic… | 2007 |
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 |
|---|---|---|---|
| K200445 | The C100 Contactless Breathing Monitor | 2020 | 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 19 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 51 ancestors have a recall of any class.
- Of its descendants, K200445 (Circadia Technologies, Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K090273.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 device is intended for the spot measurement of respiration rate of an adult patient in a hospital and clinical setting. It is not a vital signs monitor or an apnea montor.
The device is suitable for use on adult patients. It should not be used on patients that exhibit uncontrolled limb movement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103631: Sleepminder Breathing Frequency Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103631
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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