Cleared Traditional

K232143 - Applanation Tonometer HT-5000 (FDA 510(k) Clearance)

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

K232143 · Huvitz Co., Ltd. · Ophthalmic device
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Oct 2023
Decision
96d
Days
Class 2
Risk

K232143 is an FDA 510(k) clearance for the Applanation Tonometer HT-5000. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Huvitz Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on October 23, 2023 after a review of 96 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 Huvitz Co., Ltd. devices

Submission Details

510(k) Number K232143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2023
Decision Date October 23, 2023
Days to Decision 96 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
14d faster than avg
Panel avg: 110d · This submission: 96d
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 Consultant

Mtechgroup
Dave Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HKY Tonometer, Manual

All 55
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K232143.
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iCare HOME2
K211355 · Icare Finland OY · Jan 2022
CATS®-D Tonometer Prism
K203850 · Cats Tonometer, LLC · Jun 2021