Cleared Traditional

K252455 - FSYX Ocular Pressure Adjusting Pump (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252455 · Balance Ophthalmics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
268d
Days
Class 2
Risk

K252455 is an FDA 510(k) clearance for the FSYX Ocular Pressure Adjusting Pump. Classified as Applicator, Negative Pressure, External, Ocular (product code QQJ), Class II - Special Controls.

Submitted by Balance Ophthalmics, Inc. (Sioux Falls, US). The FDA issued a Cleared decision on April 30, 2026 after a review of 268 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5000 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Balance Ophthalmics, Inc. devices

Submission Details

510(k) Number K252455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2025
Decision Date April 30, 2026
Days to Decision 268 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 110d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QQJ Applicator, Negative Pressure, External, Ocular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5000
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.