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FDA 510(k)

AeroDR TX c02

K-Number: K253446 · 2026-04-10

ApplicantDk Medical Systems Co., Ltd.
Decision Date2026-04-10
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AeroDR TX c02 is a medical device manufactured by Dk Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2026-04-10 under approval number K253446. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AeroDR TX c02?

AeroDR TX c02 is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by Dk Medical Systems Co., Ltd.. The 510(k) number is K253446.

When was AeroDR TX c02 approved by the FDA?

AeroDR TX c02 received FDA 510(k) clearance on 2026-04-10, under approval number K253446.

What company makes AeroDR TX c02?

AeroDR TX c02 is manufactured by Dk Medical Systems Co., Ltd..

What is the FDA product code for AeroDR TX c02?

The FDA product code for AeroDR TX c02 is KPR.

Other Devices by Dk Medical Systems Co., Ltd.

K250790INNOVISION-DXII K250750INNOVISION-P5

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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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