FDA 510(k)

Jada System (Jada-2002)

K-Number: K253642 · 2026-05-15

Decision Date2026-05-15

Product CodeOQY

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Jada System (Jada-2002) is the device name listed in this FDA 510(k) record. The listed applicant is Organon, LLC. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K253642. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Jada System (Jada-2002)?

Jada System (Jada-2002) is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Organon, LLC. The 510(k) number is K253642.

When did Jada System (Jada-2002) receive FDA 510(k) clearance?

Jada System (Jada-2002) received FDA 510(k) clearance on 2026-05-15, under 510(k) number K253642.

Who is the listed applicant for Jada System (Jada-2002)?

The FDA 510(k) record lists Organon, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Jada System (Jada-2002)?

The FDA product code for Jada System (Jada-2002) is OQY.

Related Devices (Code: OQY)

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.

K230849ELLAVI UBTSinapi Biomedical (Pty) , Ltd.K223098Bakri Essential Postpartum BalloonCook Incorporated K212757Jada SystemAlydia Health K201199Jada SystemAlydia Health K191264Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)Ujenzi Charitable Trust K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.