BedDot (G1)— 510(k) K253274

Name: FDA 510(k) clearance K253274
Creator: U.S. Food and Drug Administration
Published: 2026-06-25

Substantially Equivalent

Intelligent Dots, LLC

FDA 510(k) clearance K253274 for BedDot (G1), Substantially Equivalent on 2026-06-25. Applicant: Intelligent Dots, LLC. Device class: 2.

Summary

BedDot (G1) from Intelligent Dots is filed under BZQ, breathing frequency monitors. The record doesn't describe the device beyond its name, the G1 designation, and the code name.

Class II, 21 CFR 868.2375. Anesthesiology is both the classification panel and the review panel. It was a Traditional 510(k).

Intelligent Dots filed from Peachtree Corner, Georgia. The decision came 269 calendar days after receipt (September 29, 2025 to June 25, 2026).

Clearance details

Applicant: Intelligent Dots, LLC
Product code: Product code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2025-09-29
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Peachtree Corner, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZQ

view all

K251326 — Respiration Rate algorithm2026-06-11
K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)2025-09-26
K250934 — Respiree Cardio- Respiratory Monitor System2025-08-05
K243183 — RTMsense Respiratory Monitoring System2025-06-27
K243966 — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)2025-04-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.