510(k) · Cleared
ClearedEllavi Ubt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sinapi Biomedical (Pty), Ltd. · OQY Intrauterine Tamponade Balloon
Cleared on Nov 13, 2023 as substantially equivalent to K170622 (Cook Incorporated, 2017) after a 230-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Nov 13, 2023
- Review
- 230 days
- Class
- Class II
- Product code
- OQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013597 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK013597 Tamponade Uterine Balloon Catheter SetCook Ob/Gyn · 2002
- 2 generations backK062438 Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn · 2006
- 1 generation backK170622 Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid…Cook Incorporated · 2017
- This deviceK230849 Ellavi UbtSinapi Biomedical (Pty), Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013597 | Tamponade Uterine Balloon Catheter Set | Cook Ob/Gyn | 2002 | — |
| −2 | K062438 | Bakri Postpartum Balloon, Model J-Sos-100500 | Cook Ob/Gyn | 2006 | — |
| −1 | K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation… | Cook Incorporated | 2017 | — |
| 0 (this device) | K230849 | Ellavi Ubt | Sinapi Biomedical (Pty), Ltd. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OQY device
- #1 K253642 Jada System (Jada-2002)score 12.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentSummary page 5…rauterine Tamponade Balloon) III. PREDICATE DEVICE The predicate device is the Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Components, K170622. The predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The ELLAVI UBT is an 18 cm lon… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K170622.
How does its category compare?
All OQY devicesOQY Intrauterine Tamponade Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OQY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OQY
Too few OQY 510(k)s in any year since 2007 to give a median.
Recalls per year · OQY
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQY
176in 2025
MAUDE reports naming product code OQY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 1 | 4 |
| 2015 | 1 | — | 1 | 5 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 55 |
| 2019 | 1 | — | 0 | 90 |
| 2020 | 1 | — | 0 | 90 |
| 2021 | 1 | — | 0 | 113 |
| 2022 | 1 | — | 0 | 274 |
| 2023 | 1 | — | 0 | 228 |
| 2024 | 0 | — | 0 | 215 |
| 2025 | 0 | — | 0 | 176 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ELLAVI UBT device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230849: Ellavi Ubt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230849
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026