Balance Ophthalmics, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Balance Ophthalmics, Inc.” (first 2026, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 268 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2026 | 1 | 268 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Balance Ophthalmics, Inc. took a median 268 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 268 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QQJ | Applicator, Negative Pressure, External, Ocular | 2 | 1 |
Review panels
- Ophthalmic (2)
Most recent Balance Ophthalmics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252455 | FSYX Ocular Pressure Adjusting Pump | QQJ | 2026-04-30 | 268 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230055 | De Novo | Applicator, Negative Pressure, External, Ocular | 2024-06-27 |
Recalls
openFDA lists no recalls under a recalling firm named Balance Ophthalmics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Balance Ophthalmics, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Balance Ophthalmics, Inc.” (first 2026, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Balance Ophthalmics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Balance Ophthalmics, Inc. is 268 days.
Which FDA product codes appear under Balance Ophthalmics, Inc.?
The most frequent FDA product codes under this applicant name are QQJ (Applicator, Negative Pressure, External, Ocular, 2).
Next steps
- See all 1 Balance Ophthalmics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QQJ, Balance Ophthalmics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.