# K151940: Thora-3Di, Model T-01

- Pathway: 510(k) (Traditional)
- Applicant: Pneumacare Limited
- Decided: Mar 10, 2016 after 240 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.
3 later devices descend from it; 1 cites it directly.
0 of 52 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 4.

## Most influential descendants
- 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
- K253650: Anura Mobile Core SDK (M1) (2026), 0 descendants of its own

## Indications for use
The Thora-3Di 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 Thora-3Di is not intended to monitor vital signs. This device is not an apnea monitor.

Source page: https://510kreport.com/device/K151940
Methodology: https://510kreport.com/methodology