Cleared Traditional

Jada System (K201199) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence.

K201199 · Alydia Health · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Aug 2020
Decision
116d
Days
Class 2
Risk

K201199 is an FDA 510(k) clearance for the Jada System. Classified as Intrauterine Tamponade Balloon (product code OQY), Class II - Special Controls.

Submitted by Alydia Health (Menlo Park, US). The FDA issued a Cleared decision on August 28, 2020 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alydia Health devices

Submission Details

510(k) Number K201199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2020
Decision Date August 28, 2020
Days to Decision 116 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 160d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OQY Intrauterine Tamponade Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
Definition Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Domecus Consulting Services, LLC
Cindy Domecus

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02883673 Completed Interventional Industry-sponsored

Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage

Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage

107
Patients (actual)
15
Sites
Treatment
Purpose
Open label
Masking
Condition studied Postpartum Hemorrhage
Study design Single group
Eligibility Female only · 18 Years+
Principal investigator Mary D'Alton, MD
Sponsor Alydia Health (industry)
Started 2017-09-17 → Primary completion 2020-01-26 → Completed 2020-03-25
Primary outcome
Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging
View full study on ClinicalTrials.gov

Regulatory Peers - OQY Intrauterine Tamponade Balloon

Devices cleared under the same product code (OQY) and FDA review panel - the closest regulatory comparables to K201199.
ELLAVI UBT
K230849 · Sinapi Biomedical (Pty) , Ltd. · Nov 2023
Bakri Essential Postpartum Balloon
K223098 · Cook Incorporated · Oct 2022
Jada System
K212757 · Alydia Health · Sep 2021
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
K191264 · Ujenzi Charitable Trust · Oct 2019
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
K170622 · Cook Incorporated · Mar 2017