Cleared Traditional

K884012 - MMAC II TONOMETER

K884012 is an FDA 510(k) clearance for MMAC II TONOMETER, manufactured by Professional Technologies Corp.. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K884012 · Professional Technologies Corp. · Ophthalmic device
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Jan 1989
Decision
106d
Days
Class 2
Risk

K884012 is an FDA 510(k) clearance for the MMAC II TONOMETER. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Professional Technologies Corp. (Redding, US). The FDA issued a Cleared decision on January 6, 1989 after a review of 106 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 Professional Technologies Corp. devices

FDA 510(k) Submission Details - K884012

510(k) Number K884012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1988
Decision Date January 06, 1989
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKX Device Classification - Class 2, Special Controls

Product Code HKX Tonometer, Ac-powered
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 - HKX Tonometer, Ac-powered

All 38
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K884012.
NIDEK MODEL NT-1000
K913189 · Nidek, Inc. · Oct 1991
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
K911721 · Keeler Instruments, Inc. · Jun 1991
BIO-RAD MODULAR AIR COMPRESSOR
K895575 · Bio-Rad · Oct 1989
KEELER PULSAIR NON CONTACT TONOMETER
K870750 · Keeler Instruments, Inc. · Mar 1987
DIGILAB MICRO ONE APPLANATION TONOMETER
K870121 · Bio-Rad · Feb 1987
SURGICAL IOP MONITOR
K863235 · Ameritek, Inc. · Sep 1986