Cleared Traditional

K182491 - Applanation tonometer AT-2

K182491 is the FDA 510(k) clearance for Applanation tonometer AT-2 by Takagi Seiko Co., Ltd.. It is a Class 2 Ophthalmic device (product code HKY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K182491 · Takagi Seiko Co., Ltd. · Ophthalmic device
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Dec 2018
Decision
90d
Days
Class 2
Risk

K182491 is an FDA 510(k) clearance for the Applanation tonometer AT-2. 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 December 10, 2018 after a review of 90 days - within the typical 510(k) review window.

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: 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 Takagi Seiko Co., Ltd. devices

Submission Details

510(k) Number K182491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2018
Decision Date December 10, 2018
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
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 16
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K182491.
Icare HOME Tonometer
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K190316 · Icare Finland OY · Jan 2020
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
K191314 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · Dec 2019
AT 030
K180839 · Carl Zeiss Meditec, AG · Jun 2018
CATS Tonometer Prism
K173904 · Cats Tonometer, LLC · Mar 2018
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K053430 · Medtronic Xomed, Inc. · Mar 2006