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FDA 510(k)

DBLG2

K-Number: K251152 · 2025-12-19

ApplicantDiabeloop
Decision Date2025-12-19
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DBLG2 is a medical device manufactured by Diabeloop. It received FDA 510(k) clearance on 2025-12-19 under approval number K251152. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DBLG2?

DBLG2 is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Diabeloop. The 510(k) number is K251152.

When was DBLG2 approved by the FDA?

DBLG2 received FDA 510(k) clearance on 2025-12-19, under approval number K251152.

What company makes DBLG2?

DBLG2 is manufactured by Diabeloop.

What is the FDA product code for DBLG2?

The FDA product code for DBLG2 is QJI.

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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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