# K020607: Sleepflo, Model 101501

- Pathway: 510(k) (Abbreviated)
- Applicant: Biomec, Inc.
- Decided: Aug 30, 2002 after 186 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: 2 generations back to K913396 (1992). 4 ancestors in all.
99 later devices descend from it; 1 cites it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982293: Pressure Transducer Airflow Sensor, Pro-Tech Services, Inc. (1998) Summary page 1.
- K940013: Body Position Indicator, Model BPI1, Pro-Tech, Inc. (1995) Summary page 1.
- K923402: Crystal Trace Piezo Respiratory Effort Sensor, Pro-Tech, Inc. (1992) Summary page 1.

## Most influential descendants
- K030379: Aplab, Model 801D0030 (2003), 98 descendants of its own
- K041904: Compass F10 System (2004), 54 descendants of its own
- K073682: Embletta Gold (2008), 41 descendants of its own
- K041724: Compass M10 System (2004), 41 descendants of its own
- K040576: Micromesam Basic-Set (2004), 31 descendants of its own

## Indications for use
SleepFLO is intended for use during sleep disorder studies to detect up to five breathing signals: airflow, body position, thoracic effort, abdominal effort and snore.

Source page: https://510kreport.com/device/K020607
Methodology: https://510kreport.com/methodology