# K100773: Kai Spot Model KMS 200

- Pathway: 510(k) (Special)
- Applicant: Kai Medical, Inc.
- Decided: Jun 23, 2010 after 97 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). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 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.

## Indications for use
The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 200 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 200 is not intended to monitor vital signs. This device is not an apnea monitor

Source page: https://510kreport.com/device/K100773
Methodology: https://510kreport.com/methodology