Cleared Traditional

K860330 - MAKLAKOV STYLE TONOMETER

K860330 is the FDA 510(k) clearance for MAKLAKOV STYLE TONOMETER by Med-Tech Develoment Corp.. It is a Class 2 Ophthalmic device (product code HKY) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K860330 · Med-Tech Develoment Corp. · Ophthalmic device
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Feb 1986
Decision
14d
Days
Class 2
Risk

K860330 is an FDA 510(k) clearance for the MAKLAKOV STYLE TONOMETER. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Med-Tech Develoment Corp. (Clearwater, US). The FDA issued a Cleared decision on February 12, 1986 after a review of 14 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 Med-Tech Develoment Corp. devices

Submission Details

510(k) Number K860330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1986
Decision Date February 12, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
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 K860330.
CATS Tonometer Prism
K173904 · Cats Tonometer, LLC · Mar 2018
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K053430 · Medtronic Xomed, Inc. · Mar 2006
PROVIEW EYE PRESSURE MONITOR
K011199 · Bausch & Lomb, Inc. · Jul 2001
JAKOBI SURG. INSTRUMENTS #6 50
K834187 · Imm Enterprises , Ltd. · Mar 1984
CONPHAR-SCHIOETZ TONOMETER
K813619 · Conphar, Inc. · Feb 1982