# K020399: Resperate; Model RR-150

- Pathway: 510(k) (Traditional)
- Applicant: Intercure, Ltd.
- Decided: Jul 2, 2002 after 146 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000405 (2000). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000405: Intercure LTD. Respi-Low, Intercure, Ltd. (2000). Our reading of the summary gave K000495, FDA’s number for Ballard Medical Products Epidural and Spinal Needles (Ballard Medical Products). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Respi-Low Model RL-108”.

## Most influential descendants
- K131586: Canary Breathing System (2013), 2 descendants of its own
- K180173: Freespira (2018), 1 descendant of its own
- K233580: A Breathing System (ABS) (2024), 0 descendants of its own
- K222101: Prism (2023), 0 descendants of its own
- K070467: Health Mask (2007), 0 descendants of its own

## Indications for use
The RXSPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions.

Source page: https://510kreport.com/device/K020399
Methodology: https://510kreport.com/methodology