# K253274: BedDot (G1)

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Dots, LLC
- Decided: Jun 25, 2026 after 269 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: 10 generations back to K910772 (1991). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152911: EarlySense Insight Sytem, Earlysense, Ltd. (2016) Summary page 5.

## Indications for use
BedDot (G1) is a non-contact, bed-mounted vital signs monitor intended to provide continuous measurement of respiratory rate (RR) within a validated operating range of 12–24 breaths/min, and movement in adult patients lying in a supine, resting position in a hospital ward or clinic setting. The operation of the BedDot (G1) has been studied in adults (weight ≥ 50Kg and weight ≤115Kg) during sleep and resting condition.

Source page: https://510kreport.com/device/K253274
Methodology: https://510kreport.com/methodology