510(k) · Cleared
ClearedFSYX Ocular Pressure Adjusting Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Balance Ophthalmics, Inc. · QQJ Applicator, Negative Pressure, External, Ocular
Cleared on Apr 30, 2026 as substantially equivalent to DEN230055 (Balance Ophthalmics, Inc., 2024) after a 268-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Apr 30, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- QQJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230055 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230055 FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) SystemBalance Ophthalmics, Inc. · 2024
- This deviceK252455 FSYX Ocular Pressure Adjusting PumpBalance Ophthalmics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230055 | FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System | Balance Ophthalmics, Inc. | 2024 | — |
| 0 (this device) | K252455 | FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. | 2026 | — |
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 QQJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN230055 | FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) SystemSummary page 5…ure system Regulatory Class: Class II Product Code: QQJ III. Predicate Device and Reference Devices Predicate Device FSYX Ocular Pressure Adjusting Pump System (DEN230055) IV. Device Description The FSYX Ocular Pressure Adjusting Pump System is comprised of a programmable pump and a… | 2024 |
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?
- Its one ancestor has no recall.
How does its category compare?
All QQJ devicesQQJ Applicator, Negative Pressure, External, Ocular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QQJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QQJ
Too few QQJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QQJ
No recall names QQJ since 2007.
Adverse event reports per year · QQJ
No MAUDE report names QQJ since 2007.
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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The FSYX™ Ocular Pressure Adjusting Pump is indicated for the reduction of lntraocular Pressure (IOP)
during sleep in adult patients with open-angle glaucoma and IOP s 21 mmHg who are currently using or
have undergone another !OP-lowering treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252455: FSYX Ocular Pressure Adjusting Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252455
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026