510(k) · Cleared
Recalled · 2010Salter Labs Oral/Nasal Thermal Airflow Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs, Division of Regulatory Affairs · BZQ Monitor, Breathing Frequency
Cleared on Jul 25, 2008 as substantially equivalent to K981445 (Braebon Medical Corp., 1998) after a 115-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 25, 2008
- Review
- 115 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981445 (1998). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK981445 Ultima Airflow Sensor, 0510Braebon Medical Corp. · 1998
- This deviceK080922 Salter Labs Oral/Nasal Thermal Airflow SensorSalter Labs, Division of Regulatory Affairs · 2008
- Descendant · cites it directly · 0 of its ownK161953 ReDe MaskTereopneuma · 2017
- Descendant · cites it directly · 0 of its ownK151874 BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal…Salter Labs · 2016
- Descendant · cites it directly · 0 of its ownK092685 Pneumotherml, Model: 5800Salter Labs · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981445 | Ultima Airflow Sensor, 0510 | Braebon Medical Corp. | 1998 | — |
| 0 (this device) | K080922 | Salter Labs Oral/Nasal Thermal Airflow Sensor | Salter Labs, Division of Regulatory Affairs | 2008 | — |
| +1 | K161953 | ReDe Mask | Tereopneuma | 2017 | — |
| +1 | K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal… | Salter Labs | 2016 | — |
| +1 | K092685 | Pneumotherml, Model: 5800 | Salter Labs | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K981445 | Ultima Airflow Sensor, 0510Summary page 1…Oral/Nasal Thermal Airflow Sensor Common Name or Usual Name Airflow Sensor Predicate Device Braebon Medical Corp. Airflow Sensor (K981445) Reason for Submission Initial Introduction into Interstate Commerce Substantial Equivalence The Salter Labs Or… | 1998 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2010 | Not classified | Z-1028-2011 | Employee error | The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Salter Labs Oral/Nasal Thermal Airflow Sensor is used as a cannula accessory with existing recording devices and data acquisition systems in a sleep laboratory setting to support the diagnostic recording of nasal and/or oral airflow. The subject device itself performs no diagnostic functions, and only supports the diagnostic recording of airflow for use as an accessory component to a polysomnography recorder.
The target population is adult and pediatric patients during a sleep study in a sleep laboratory.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080922: Salter Labs Oral/Nasal Thermal Airflow Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080922
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