# K252455: FSYX Ocular Pressure Adjusting Pump

- Pathway: 510(k) (Traditional)
- Applicant: Balance Ophthalmics, Inc.
- Decided: Apr 30, 2026 after 268 days
- Product code: QQJ (Applicator, Negative Pressure, External, Ocular)
- Device class: 2
- Regulation: 21 CFR 886.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230055 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230055: FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System, Balance Ophthalmics, Inc. (2024) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K252455
Methodology: https://510kreport.com/methodology