Cleared Traditional

K930447 - MARCO H AND TS-1 INSTRUMENT TABLES

K930447 is an FDA 510(k) clearance for MARCO H AND TS-1 INSTRUMENT TABLES, manufactured by Marco Ophthalmic, Inc.. The device is a Class 1 Ophthalmic device with product code HRJ cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K930447 · Marco Ophthalmic, Inc. · Ophthalmic device
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Jul 1993
Decision
161d
Days
Class 1
Risk

K930447 is an FDA 510(k) clearance for the MARCO H AND TS-1 INSTRUMENT TABLES. Classified as Table, Instrument, Powered, Ophthalmic (product code HRJ), Class I - General Controls.

Submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 6, 1993 after a review of 161 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4855 - 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 Marco Ophthalmic, Inc. devices

FDA 510(k) Submission Details - K930447

510(k) Number K930447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date July 06, 1993
Days to Decision 161 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
51d slower than avg
Panel avg: 110d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

HRJ Device Classification - Class 1, General Controls

Product Code HRJ Table, Instrument, Powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4855
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HRJ Table, Instrument, Powered, Ophthalmic

Devices cleared under the same product code (HRJ) and FDA review panel - the closest regulatory comparables to K930447.
910T MONTORIZED INSTRUMENT TABLE
K922242 · R.H. Burton Co. · Sep 1992
TBD, LENS MEASURING DEVICE
K912134 · Alcon Laboratories · Jul 1991
RELIANCE 1379
K853359 · Dentsply Intl. · Sep 1985
WOODLYN CLASSIC INSTRUMENT STAND
K841760 · Woodlyn, Inc. · Jun 1984
MACHEMER/TANO ROTATING
K833820 · Optical Micro Systems, Inc. · Jan 1984