510(k) · Cleared
ClearedBiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs · MNR Ventilatory Effort Recorder
Cleared on Apr 15, 2016 as substantially equivalent to K051313 (Salter Labs, 2005) and 1 other predicate after a 281-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Apr 15, 2016
- Review
- 281 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913396 (1992). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 2 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 1 generation backK051313 BI-Naps Nasal Airflow and Snore TransducerSalter Labs · 2005
- This deviceK151874 BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal…Salter Labs · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −2 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −1 | K051313 | BI-Naps Nasal Airflow and Snore Transducer | Salter Labs | 2005 | — |
| 0 (this device) | K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal… | Salter Labs | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2008 | 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 MNR? 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 MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 12 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 |
|---|---|---|---|
| * | K051313 | BI-Naps Nasal Airflow and Snore TransducerSummary page 4…Classification Panel: Anaesthesiology Predicate Devices: This submission demonstrates substantial equivalence to the predicate devices: K051313, Airflow Pressure Transducer K080922, Airflow Sensor www.salterlabs.com Telephone: 760-795-7100 Fax: 760-683-6797 ===… | 2005 |
| * | K080922 | Salter Labs Oral/Nasal Thermal Airflow SensorSummary page 4…hesiology Predicate Devices: This submission demonstrates substantial equivalence to the predicate devices: K051313, Airflow Pressure Transducer K080922, Airflow Sensor www.salterlabs.com Telephone: 760-795-7100 Fax: 760-683-6797 Salter Labs K151874 Sleep Diagno… | 2008 |
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 24 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K051313.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, 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 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
What is it indicated for?
The BiNAPS Nasal Airflow Pressure and Snore Transducer (using the pressure transducer) is an accessory intended for use with polysomnography equipment during sleep disorder studies for the purpose of detecting and amplifying breathing signals and detection of snoring of a sleeping patient through a Salter Labs nasal cannula. This device is intended for adult and pediatric (excluding neonatal and infant) use. The ThermiSense Oral/Nasal Thermal AirFlow…
Read the full statement (127 words)
The BiNAPS Nasal Airflow Pressure and Snore Transducer (using the pressure transducer) is an accessory intended for use with polysomnography equipment during sleep disorder studies for the purpose of detecting and amplifying breathing signals and detection of snoring of a sleeping patient through a Salter Labs nasal cannula. This device is intended for adult and pediatric (excluding neonatal and infant) use.
The ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is a thermal resistive thermistor designed to monitor oral/nasal thermal airflow temperature and pressure changes during sleep studies. The ThermiSense is intended for use with a nasal cannula and polysomnography headbox or pressure transducers, such as, BINAPS Nasal Airflow Transducer. This device is intended for adult and pediatric (excluding neonatal and infant) use.
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/K151874 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151874: BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151874
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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