# K103631: Sleepminder Breathing Frequency Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Biancamed Limited
- Decided: Jul 21, 2011 after 220 days
- Product code: BZQ (Monitor, Breathing Frequency)
- 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: 7 generations back to K913396 (1992). 51 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090273: Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100, Kai Sensors, Inc. (2009) Summary page 1.
- K060708: Somnoscreen, Somnomedics GmbH & Co. KG (2007) Summary page 1.

## Most influential descendants
- K200445: The C100 Contactless Breathing Monitor (2020), 0 descendants of its own

## Indications for use
The device is intended for the spot measurement of respiration rate of an adult patient in a hospital and clinical setting. It is not a vital signs monitor or an apnea montor. The device is suitable for use on adult patients. It should not be used on patients that exhibit uncontrolled limb movement.

Source page: https://510kreport.com/device/K103631
Methodology: https://510kreport.com/methodology