FDA product code OQY: Intrauterine Tamponade Balloon
OQY is the FDA product code for intrauterine tamponade balloon. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 11 510(k) submissions under OQY, 3 in the last five years, from 8 different applicants. The average 510(k) review took 123 days (median 116); 177 days on average over the last three years. FDA has posted 2 recalls for OQY devices.
Definition
provides temporary control or reduction of postpartum uterine bleeding
Classification
| Field | Value |
|---|---|
| Device name | Intrauterine Tamponade Balloon |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for OQY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 30 |
| 2019 | 1 | 173 |
| 2020 | 1 | 116 |
| 2021 | 1 | 30 |
| 2022 | 1 | 28 |
| 2023 | 1 | 230 |
| 2026 | 1 | 177 |
Compare with all 510(k) review times · Search every OQY clearance
Top OQY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Incorporated | 2 | 2022-10-28 |
| Alydia Health | 2 | 2021-09-30 |
| Clinical Innovations, LLC | 2 | 2016-01-14 |
| Organon, LLC | 1 | 2026-05-15 |
| Sinapi Biomedical (Pty) , Ltd. | 1 | 2023-11-13 |
3 more applicants have OQY clearances. See the full list in Caduvo.
Most recent OQY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253642 | Organon, LLC | Jada System (Jada-2002) | 2026-05-15 | 177 |
| K230849 | Sinapi Biomedical (Pty) , Ltd. | ELLAVI UBT | 2023-11-13 | 230 |
| K223098 | Cook Incorporated | Bakri Essential Postpartum Balloon | 2022-10-28 | 28 |
| K212757 | Alydia Health | Jada System | 2021-09-30 | 30 |
| K201199 | Alydia Health | Jada System | 2020-08-28 | 116 |
Recalls for OQY devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-01-05.
Frequently asked questions
What is FDA product code OQY?
OQY is the FDA product code for intrauterine tamponade balloon. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is OQY?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code OQY?
Across 11 cleared submissions the average was 123 days from receipt to decision (median 116).
Which companies have the most OQY clearances?
Cook Incorporated (2); Alydia Health (2); Clinical Innovations, LLC (2); Organon, LLC (1); Sinapi Biomedical (Pty) , Ltd. (1).
Have OQY devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-01-05.
Next steps
- Run an FDA pathway report with predicate devices for product code OQY
- Run a recall and safety report across every OQY manufacturer
- Watch product code OQY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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