# K254058: DistaSense (TM) (v1)

- Pathway: 510(k) (Traditional)
- Applicant: Life Detection Technologies
- Decided: Sep 25, 2026 after 282 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K830295 (1983). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223163: Sleepiz One+, Sleepiz AG (2023) Summary page 5.

## Indications for use
The DistaSense(TM) System is a contactless medical device intended to measure heart rate and respiration rate in healthy adult patients, at rest or during sleep (in a non-motion condition) the DistaSense(TM) System is intended to be used by healthcare professionals, caregivers, and patients, with recordings performed in either a clinical setting or in a home environment. The DistaSense(TM) web application is intended for use by healthcare professionals only. This device is not indicated for active patient monitoring, rather, it is intended for retrospective data review in healthy patients. The device is not indicated for use in pregnant women or patients with active implantable devices.

Source page: https://510kreport.com/device/K254058
Methodology: https://510kreport.com/methodology