FDA product code QQJ: Applicator, Negative Pressure, External, Ocular
QQJ is the FDA product code for applicator, negative pressure, external, ocular. It is a Class II device, regulated under 21 CFR 886.5000 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under QQJ, 1 in the last five years. The average 510(k) review took 268 days (median 268); 268 days on average over the last three years. 1 De Novo request was granted under it.
Definition
External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients.
Classification
| Field | Value |
|---|---|
| Device name | Applicator, Negative Pressure, External, Ocular |
| Device class | Class II |
| Regulation | 21 CFR 886.5000 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for QQJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 268 |
Compare with all 510(k) review times · Search every QQJ clearance
Top QQJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Balance Ophthalmics, Inc. | 1 | 2026-04-30 |
Most recent QQJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252455 | Balance Ophthalmics, Inc. | FSYX Ocular Pressure Adjusting Pump | 2026-04-30 | 268 |
Recalls for QQJ devices
openFDA lists no recalls for product code QQJ.
Frequently asked questions
What is FDA product code QQJ?
QQJ is the FDA product code for applicator, negative pressure, external, ocular. It is a Class II device, regulated under 21 CFR 886.5000 and reviewed by the Ophthalmic panel.
What device class is QQJ?
Class II, regulation 21 CFR 886.5000. Typical premarket route: 510(k).
How long does a 510(k) take for product code QQJ?
Across 1 cleared submissions the average was 268 days from receipt to decision (median 268).
Which companies have the most QQJ clearances?
Balance Ophthalmics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QQJ
- Run a recall and safety report across every QQJ manufacturer
- Watch product code QQJ 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times