DRE Duo
K-Number: K260482 · 2026-06-15
Device Summary
Frequently Asked Questions
What is the DRE Duo?
DRE Duo is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Jpi Healthcare Co, Ltd.. The 510(k) number is K260482.
When did DRE Duo receive FDA 510(k) clearance?
DRE Duo received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260482.
Who is the listed applicant for DRE Duo?
The FDA 510(k) record lists Jpi Healthcare Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DRE Duo?
The FDA product code for DRE Duo is KPR.
Other records listing Jpi Healthcare Co, Ltd. as applicant
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.
Related Devices (Code: KPR)
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.
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.