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The Tracker / October 2026 / K262284

510(k) cleared

KIM BLUE

Desarrollo e Investigación Médica Aragonesa S.L. · Oct 16, 2026 · K262284

FDA cleared the KIM BLUE from Desarrollo e Investigación Médica Aragonesa S.L. on Oct 16, 2026 under K262284, a traditional 510(k). The device falls under product code OTN, Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, regulated at 21 CFR 878.3300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 6, 2026. The decision came 102 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Desarrollo e Investigación Médica Aragonesa S.L. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262284?

K262284 is the FDA 510(k) for KIM BLUE, submitted by Desarrollo e Investigación Médica Aragonesa S.L.. FDA's decision date was Oct 16, 2026, under product code OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator).

Who makes the KIM BLUE?

Desarrollo e Investigación Médica Aragonesa S.L., based in Calatayud, is the applicant of record for K262284.

How long did the K262284 review take?

FDA received the submission on Jul 6, 2026 and issued its decision on Oct 16, 2026, 102 days later.

← All decisions in October 2026

Sources