# K000405: Intercure LTD. Respi-Low

- Pathway: 510(k) (Traditional)
- Applicant: Intercure, Ltd.
- Decided: May 17, 2000 after 100 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
No predicates in its family tree.
6 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020399: Resperate; Model RR-150 (2002), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K000405
Methodology: https://510kreport.com/methodology