Cleared Traditional

K172728 - Applanation tonometer AT-1 (FDA 510(k) Clearance)

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

K172728 · Takagi Seiko Co., Ltd. · Ophthalmic device
Oct 2017
Decision
36d
Days
Class 2
Risk

K172728 is an FDA 510(k) clearance for the Applanation tonometer AT-1. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Takagi Seiko Co., Ltd. (Nakano-Shi, JP). The FDA issued a Cleared decision on October 17, 2017 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K172728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2017
Decision Date October 17, 2017
Days to Decision 36 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 156d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKY Tonometer, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
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.