Cleared Traditional

K142263 - Applanation Tonometer

K142263 is the FDA 510(k) clearance for Applanation Tonometer by Shanghai Mediworks Precision Instruments Co. , Ltd.. It is a Class 2 Ophthalmic device (product code HKY) cleared through the Traditional 510(k) pathway after a 610-day FDA review.

K142263 · Shanghai Mediworks Precision Instruments Co. , Ltd. · Ophthalmic device
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Apr 2016
Decision
610d
Days
Class 2
Risk

K142263 is an FDA 510(k) clearance for the Applanation Tonometer. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Shanghai Mediworks Precision Instruments Co. , Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 15, 2016 after a review of 610 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Shanghai Mediworks Precision Instruments Co. , Ltd. devices

Submission Details

510(k) Number K142263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2014
Decision Date April 15, 2016
Days to Decision 610 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
500d slower than avg
Panel avg: 110d · This submission: 610d
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 K142263.
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