510(k) · Cleared
ClearedAlphamed Gemini Sensor, Snoring Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphamed, Inc. · MNR Ventilatory Effort Recorder
Cleared on Jun 1, 1999 as substantially equivalent to K913749 (Edentec Corp., 1992) and 1 other predicate after a 120-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Jun 1, 1999
- Review
- 120 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913749 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K040069Dymedix Reusable Airflow/Snore SensorDymedix, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913749 | Edentrace Airflow 3171/Sleep Lab Airflow 3170 | Edentec Corp. | 1992 | — |
| 0 (this device) | K990321 | Alphamed Gemini Sensor, Snoring Sensor | Alphamed, Inc. | 1999 | — |
| +1 | K040069 | Dymedix Reusable Airflow/Snore Sensor | Dymedix, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K913749 | Edentrace Airflow 3171/Sleep Lab Airflow 3170Summary page 1…onitor. Class II, BZQ Predicate snoring sensors have been found substantially equivalent to 21 CFR 868.2375, Ventilatory Effort Recorder, Class II, MNR 510(k) Number: K913749 Manufacture: EdenTec inc. Trade Name: EdenTrace Airflow Cable Model 3171and Sleep Lab Airflow Cable Model 3170 Sensor 510(k) N… | 1992 |
| * | K940015 | Snoring Microphone, SM1Summary page 1…s II, MNR 510(k) Number: K913749 Manufacture: EdenTec inc. Trade Name: EdenTrace Airflow Cable Model 3171and Sleep Lab Airflow Cable Model 3170 Sensor 510(k) Number: K940015 Manufacture: Pro-Tech Inc. Trade Name: Snoring Microphone 1.0 Description of Sensors The Breathing/Snoring Sensors and Snoring… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040069 | Dymedix Reusable Airflow/Snore Sensor | 2004 | 0 |
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 disposable AlphaMed Inc. Breathing/Snoring Sensors and Snoring Sensor are used with existing recording devices in support of diagnostic recording of nasal and oral airflow and recording of breath sounds. The sensors are used with patients who require a sleep study recording.
The sensors are contraindicated for support of apnea 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/K990321 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990321: Alphamed Gemini Sensor, Snoring Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990321
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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