# K040605: Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb Movement Sensor, Model 3100

- Pathway: 510(k) (Abbreviated)
- Applicant: Dymedix, Inc.
- Decided: Apr 26, 2004 after 49 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: 1 generation back to K923402 (1992). 3 ancestors in all.
100 later devices descend from it; 2 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001030: Respiratory Belt Sensor, Model 6000S; Limb Movement Sensor, Model 3000S, Dymedix, Inc. (2000) Summary page 1.
- K923402: Crystal Trace Piezo Respiratory Effort Sensor, Pro-Tech, Inc. (1992) Summary page 1.
- K940014: PLM Sensor, Model PLM1, Pro-Tech, Inc. (1994) Summary page 1.

## Most influential descendants
- K061993: Equivital, Model EQ-01 (2006), 99 descendants of its own
- K113054: Equivital (2012), 71 descendants of its own
- K141167: Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software Library) (2014), 70 descendants of its own
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch (2015), 43 descendants of its own
- K081140: Visensia (2008), 22 descendants of its own

## Indications for use
The DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.

Source page: https://510kreport.com/device/K040605
Methodology: https://510kreport.com/methodology