Jada System (Jada-2002)
FDA 510(k) K253642 · Organon, LLC
510(k) numberK253642
Submission
- Device name
- Jada System (Jada-2002)
- Applicant
- Organon, LLC
Jersey City, NJ, US - Received
- November 19, 2025
- Decision date
- May 15, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OQY – Intrauterine Tamponade Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
provides temporary control or reduction of postpartum uterine bleeding
Other 510(k)s with product code OQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230849 | Ellavi UbtOQY · Traditional | Sinapi Biomedical (Pty) , Ltd. | 11/13/2023SE |
| K223098 | Bakri Essential Postpartum BalloonOQY · Special | Cook Incorporated | 10/28/2022SE |
| K212757 | Jada SystemOQY · Special | Alydia Health | 09/30/2021SE |
| K201199 | Jada SystemOQY · Traditional | Alydia Health | 08/28/2020SE |
| K191264 | Every Second Matters-Uterine Balloon Tamponade (ESM-UBT)OQY · Traditional | Ujenzi Charitable Trust | 10/30/2019SE |
| K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentOQY · Special | Cook Incorporated | 03/31/2017SE |
| K153591 | ebb Complete Tamponade SystemOQY · Special | Clinical Innovations, LLC | 01/14/2016SE |
| K150573 | ebb Complete Tamponade SystemOQY · Special | Clinical Innovations, LLC | 03/25/2015SE |
| K101535 | Bt-CathOQY · Traditional | Utah Medical Products, Inc. | 01/11/2011SE |
| K091958 | Belfort-Dildy Obstetric Tamponade SystemOQY · Traditional | Glenveigh Surgical, LLC | 04/30/2010SE |
More from Glenveigh Surgical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K950861 | Reconstitution AccessoreisFPK · Traditional | 05/26/1995SE |
| K853388 | Monosticon Uni-DotKTN · Traditional | 08/22/1985SE |
| K842314 | Duoclon Color-CeptJHJ · Traditional | 08/24/1984SE |
| K841525 | Oreia II B-Hcg Pregnancy Test KitJHI · Traditional | 06/05/1984SE |
| K841602 | Accurate Beta 30 Pregnancy Test KitLCX · Traditional | 05/22/1984SE |
| K840650 | B-Neocept 30JHJ · Traditional | 04/04/1984SE |
| K832801 | Oreia II B-Hcg, Enzyme InnunoassayJHI · Traditional | 12/08/1983SE |
| K831339 | Neo-Pregnosticon Duoclon Tube TestJHJ · Traditional | 06/08/1983SE |
| K831109 | Duoclon Slide TestJHI · Traditional | 06/02/1983SE |
| K823682 | Beta Ffirm TestJHJ · Traditional | 01/07/1983SE |
Questions and answers
When was Jada System (Jada-2002) cleared by the FDA?
Jada System (Jada-2002) (K253642) received a 510(k) decision of Substantially Equivalent on May 15, 2026, 177 days after the submission was received.
What is the product code of K253642?
The FDA product code is OQY – Intrauterine Tamponade Balloon, a Class II (moderate risk) device regulated under 21 CFR 884.4530.