# K090273: Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Kai Sensors, Inc.
- Decided: Jun 5, 2009 after 121 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: 6 generations back to K913396 (1992). 47 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012451: Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246, Welch Allyn Protocol, Inc. (2001) Summary page 1.
- K043132: Universal Xacttrace, Medcare Flaga (2004) Summary page 1.
- K073682: Embletta Gold, Embla Systems, Inc. (2008) Summary page 1.
- K971813: EMBLA, Ferguson Medical (1998) Summary page 1.

## Most influential descendants
- K151940: Thora-3Di, Model T-01 (2016), 3 descendants of its own
- K242001: Philips VSC-MEDlib (2025), 2 descendants of its own
- K243966: FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (2025), 1 descendant of its own
- K103631: Sleepminder Breathing Frequency Indicator (2011), 1 descendant of its own
- K253650: Anura Mobile Core SDK (M1) (2026), 0 descendants of its own

## Indications for use
The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 is intended for a one-time measurement of respiratory rate as part of a vital signs assessment. The device is indicated for hospital or clinical use in adult patients. The device is intended to be operated by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider. The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 is not intended to monitor vital signs. This device is not an apnea monitor

Source page: https://510kreport.com/device/K090273
Methodology: https://510kreport.com/methodology