Cleared Traditional

ELLAVI UBT (K230849) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230849 · Sinapi Biomedical (Pty) , Ltd. · Obstetrics & Gynecology device
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Nov 2023
Decision
230d
Days
Class 2
Risk

K230849 is an FDA 510(k) clearance for the ELLAVI UBT. Classified as Intrauterine Tamponade Balloon (product code OQY), Class II - Special Controls.

Submitted by Sinapi Biomedical (Pty) , Ltd. (Stellenbosch, ZA). The FDA issued a Cleared decision on November 13, 2023 after a review of 230 days - an extended review cycle.

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 Sinapi Biomedical (Pty) , Ltd. devices

Submission Details

510(k) Number K230849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2023
Decision Date November 13, 2023
Days to Decision 230 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
70d slower than avg
Panel avg: 160d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Smith Associates
Yolanda R Smith

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.

Regulatory Peers - OQY Intrauterine Tamponade Balloon

Devices cleared under the same product code (OQY) and FDA review panel - the closest regulatory comparables to K230849.
Jada System (Jada-2002)
K253642 · Organon, LLC · May 2026
Bakri Essential Postpartum Balloon
K223098 · Cook Incorporated · Oct 2022
Jada System
K212757 · Alydia Health · Sep 2021
Jada System
K201199 · Alydia Health · Aug 2020
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