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FDA 510(k)

KIM BLUE

K-Number: K262284 · 2026-10-16

ApplicantDesarrollo e Investigación Médica Aragonesa S.L.
Decision Date2026-10-16
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KIM BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Desarrollo e Investigación Médica Aragonesa S.L.. It received FDA 510(k) clearance on 2026-10-16 under 510(k) number K262284. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIM BLUE?

KIM BLUE is a medical device that received FDA 510(k) clearance on 2026-10-16. The listed applicant is Desarrollo e Investigación Médica Aragonesa S.L.. The 510(k) number is K262284.

When did KIM BLUE receive FDA 510(k) clearance?

KIM BLUE received FDA 510(k) clearance on 2026-10-16, under 510(k) number K262284.

Who is the listed applicant for KIM BLUE?

The FDA 510(k) record lists Desarrollo e Investigación Médica Aragonesa S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIM BLUE?

The FDA product code for KIM BLUE is OTN.

Related Devices (Code: OTN)

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.

K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK222293ArcSP Suprapubic Sling SystemUrocure, LLCK222468ArcTO Transobturator Sling SystemUrocure, LLCK211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK210087Athena Surgical RMUS SystemAthena Surgical, LLC

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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