Cleared Traditional

K152890 - SACCADOMETER PLUS, SACCADOMETER ADVANCED (FDA 510(k) Clearance)

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

K152890 · Ober Consulting Sp. Z.O.O. · Ophthalmic device
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Aug 2016
Decision
316d
Days
Class 2
Risk

K152890 is an FDA 510(k) clearance for the SACCADOMETER PLUS, SACCADOMETER ADVANCED. Classified as Monitor, Eye Movement (product code HLL), Class II - Special Controls.

Submitted by Ober Consulting Sp. Z.O.O. (Poznan, PL). The FDA issued a Cleared decision on August 11, 2016 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1510 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K152890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date August 11, 2016
Days to Decision 316 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 110d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLL Monitor, Eye Movement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1510
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.