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510(k) K253642

Jada System (Jada-2002) by Organon, LLC — Product Code OQY

K253642 is an FDA 510(k) premarket notification submitted by Organon, LLC for the device "Jada System (Jada-2002)". The FDA issued a decision of Substantially Equivalent on May 15, 2026. The device falls under product code OQY (Intrauterine Tamponade Balloon), a Class II device regulated under 21 CFR 884.4530. Organon, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2026
Date Received
November 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intrauterine Tamponade Balloon
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

provides temporary control or reduction of postpartum uterine bleeding

Other clearances by Organon, LLC

  • K950861 — RECONSTITUTION ACCESSOREIS (May 26, 1995)
  • K853388 — MONOSTICON UNI-DOT (August 22, 1985)
  • K842314 — DUOCLON COLOR-CEPT (August 24, 1984)
  • K841525 — OREIA II B-HCG PREGNANCY TEST KIT (June 5, 1984)
  • K841602 — ACCURATE BETA 30 PREGNANCY TEST KIT (May 22, 1984)
  • K840650 — B-NEOCEPT 30 (April 4, 1984)
  • K832801 — OREIA II B-HCG, ENZYME INNUNOASSAY (December 8, 1983)
  • K831339 — NEO-PREGNOSTICON DUOCLON TUBE TEST (June 8, 1983)
  • K831109 — DUOCLON SLIDE TEST (June 2, 1983)
  • K823682 — BETA FFIRM TEST (January 7, 1983)

Other clearances for product code OQY

  • K230849 — ELLAVI UBT (November 13, 2023)
  • K223098 — Bakri Essential Postpartum Balloon (October 28, 2022)
  • K212757 — Jada System (September 30, 2021)
  • K201199 — Jada System (August 28, 2020)
  • K191264 — Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) (October 30, 2019)
  • K170622 — Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Compo (March 31, 2017)
  • K153591 — ebb Complete Tamponade System (January 14, 2016)
  • K150573 — ebb Complete Tamponade System (March 25, 2015)
  • K101535 — BT-CATH (January 11, 2011)
  • K091958 — BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM (April 30, 2010)

FDA data resources