Cleared Traditional

K172728 - Applanation tonometer AT-1

K172728 is the FDA 510(k) clearance for Applanation tonometer AT-1 by Takagi Seiko Co., Ltd.. It is a Class 2 Ophthalmic device (product code HKY) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K172728 · Takagi Seiko Co., Ltd. · Ophthalmic device
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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.

View all Takagi Seiko Co., Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 110d · 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.

Regulatory Peers - HKY Tonometer, Manual

All 17
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K172728.
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