# K990321: Alphamed Gemini Sensor, Snoring Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Alphamed, Inc.
- Decided: Jun 1, 1999 after 120 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913749 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913749: Edentrace Airflow 3171/Sleep Lab Airflow 3170, Edentec Corp. (1992) Summary page 1.
- K940015: Snoring Microphone, SM1, Pro-Tech, Inc. (1995) Summary page 1.

## Most influential descendants
- K040069: Dymedix Reusable Airflow/Snore Sensor (2004), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K990321
Methodology: https://510kreport.com/methodology