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FDA 510(k)

BedDot (G1)

K-Number: K253274 · 2026-06-25

ApplicantIntelligent Dots, LLC
Decision Date2026-06-25
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BedDot (G1) is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Dots, LLC. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K253274. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BedDot (G1)?

BedDot (G1) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Intelligent Dots, LLC. The 510(k) number is K253274.

When did BedDot (G1) receive FDA 510(k) clearance?

BedDot (G1) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253274.

Who is the listed applicant for BedDot (G1)?

The FDA 510(k) record lists Intelligent Dots, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BedDot (G1)?

The FDA product code for BedDot (G1) is BZQ.

Related Devices (Code: BZQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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