510(k) · Cleared
ClearedPressure Transducer Airflow Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro-Tech Services, Inc. · MNR Ventilatory Effort Recorder
Cleared on Jul 13, 1998 as substantially equivalent to K913396 (Pro-Tech, Inc., 1992) after a 12-day review. Its family tree reaches back 1 generation to 1992. 106 later devices descend from it.
- Decided
- Jul 13, 1998
- Review
- 12 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913396 (1992). 106 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- This deviceK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- Descendant · cites it directly · 99 of its ownK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- Descendant · 2 generations on · 98 of its ownK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- Descendant · 3 generations on · 54 of its ownK041904 Compass F10 SystemMedcare Flaga · 2004
- Descendant · 4 generations on · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 41 of its ownK041724 Compass M10 SystemMedcare Flaga · 2004
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K020607Sleepflo, Model 101501Biomec, Inc. · 2002 · cites it directly99descendants
- K030379Aplab, Model 801D0030Sector Medical Corp. · 2003 · 2 generations on98descendants
- K041904Compass F10 SystemMedcare Flaga · 2004 · 3 generations on54descendants
- K073682Embletta GoldEmbla Systems, Inc. · 2008 · 4 generations on41descendants
- K041724Compass M10 SystemMedcare Flaga · 2004 · 3 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| 0 (this device) | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| +1 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| +2 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| +3 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| +4 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| +3 | K041724 | Compass M10 System | Medcare Flaga | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 14 | 0 |
| 2026 | 10 | 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 |
|---|---|---|---|
| * | K913396 | Cannula Style ThermocouplesSummary page 1…Sensor CLASSIFICATION NAME: Breathing Frequency Monitor (per CFR 868.1860) PREDICATE DEVICE: Cannula-Style Thermocouple Airflow Sensor, Pro-Tech Services, Inc. 510(k) #K913396 DESCRIPTION OF THE DEVICE: The Pressure Transducer Airflow Sensor is a small interface device which converts low levels of air… | 1992 |
What descends from it? (106)
See all 1064 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?
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 Pressure Transducer Airflow Sensor is indicated for use during sleep disorder studies to detect respiratory airflow onto a physiological recorder. It is a battery-powered device, with a disposable nasal cannula that attaches to the patient and connects into the input of the Pressure Transducer Airflow Sensor device. The outputs of the device provide low-level voltage signals that are intended to be input to a physiological recorder.
It can be used for pediatric patients - 2 years and above, and adult patients, to and including geriatric patients. The device is not intended for pediatric and infants below 2 years of age for the purpose of respiration or SIDS monitoring.
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/K982293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982293: Pressure Transducer 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/K982293
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