510(k) · Cleared
ClearedBI-Naps Nasal Airflow and Snore Transducer
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 Sep 15, 2005 as substantially equivalent to K982293 (Pro-Tech Services, Inc., 1998) after a 119-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it.
- Decided
- Sep 15, 2005
- Review
- 119 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913396 (1992). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 1 generation backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- This deviceK051313 BI-Naps Nasal Airflow and Snore TransducerSalter Labs · 2005
- 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 ownK082853 Clinical Oxygen Dose Recorder (Codr), Model 300-CRInspired Technologies, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK080983 Provent Nasal CannulaVentus Medical, Inc. · 2008 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor…Salter Labs · 2016 · cites it directly0descendants
- K082853Clinical Oxygen Dose Recorder (Codr), Model 300-CRInspired Technologies, Inc. · 2009 · cites it directly0descendants
- K080983Provent Nasal CannulaVentus Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −1 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| 0 (this device) | K051313 | BI-Naps Nasal Airflow and Snore Transducer | Salter Labs | 2005 | — |
| +1 | K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal… | Salter Labs | 2016 | — |
| +1 | K082853 | Clinical Oxygen Dose Recorder (Codr), Model 300-CR | Inspired Technologies, Inc. | 2009 | — |
| +1 | K080983 | Provent Nasal Cannula | Ventus Medical, Inc. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K982293 | Pressure Transducer Airflow SensorSummary page 1…re Transducer Proprietary Name B6-NAPS Nasal Airflow and Snore Transducer Predicate Device Pro-Tech Pressure Transducer 510(k) #K982293 Reason for Submission Initial Introduction into Interstate Commerce Substantial Equivalence The Salter Labs Airf… | 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)
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 13 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151874 (Salter Labs, 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K982293.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Salter Labs BiNAPS Airflow 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051313: BI-Naps Nasal Airflow and Snore Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051313
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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