510(k) · Cleared
ClearedEdentrace Airflow 3171/Sleep Lab Airflow 3170
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edentec Corp. · BZQ Monitor, Breathing Frequency
Cleared on Jul 2, 1992 after a 316-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jul 2, 1992
- Review
- 316 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK913749 Edentrace Airflow 3171/Sleep Lab Airflow 3170Edentec Corp. · 1992
- Descendant · cites it directly · 1 of its ownK990321 Alphamed Gemini Sensor, Snoring SensorAlphamed, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK180001 Disposable BreathSensor Adult, Disposable BreathSensor Small Adult /…Embla Systems · 2019
- Descendant · 2 generations on · 0 of its ownK040069 Dymedix Reusable Airflow/Snore SensorDymedix, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See all- K990321Alphamed Gemini Sensor, Snoring SensorAlphamed, Inc. · 1999 · cites it directly1descendant
- K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable…Embla Systems · 2019 · cites it directly0descendants
- K040069Dymedix Reusable Airflow/Snore SensorDymedix, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913749 | Edentrace Airflow 3171/Sleep Lab Airflow 3170 | Edentec Corp. | 1992 | — |
| +1 | K990321 | Alphamed Gemini Sensor, Snoring Sensor | Alphamed, Inc. | 1999 | — |
| +1 | K180001 | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child… | Embla Systems | 2019 | — |
| +2 | K040069 | Dymedix Reusable Airflow/Snore Sensor | Dymedix, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 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?
- Of its descendants, K990321 (Alphamed, Inc., 1999) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K913749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913749: Edentrace Airflow 3171/Sleep Lab Airflow 3170.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913749
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026