Cleared Traditional

K912514 - TANDEM SCANNING MICROSCOPE

K912514 is an FDA 510(k) clearance for TANDEM SCANNING MICROSCOPE, manufactured by Tandem Scanning Corp.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K912514 · Tandem Scanning Corp. · Ophthalmic device
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Dec 1991
Decision
193d
Days
Class 2
Risk

K912514 is an FDA 510(k) clearance for the TANDEM SCANNING MICROSCOPE. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Tandem Scanning Corp. (Bethesda, US). The FDA issued a Cleared decision on December 16, 1991 after a review of 193 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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 Tandem Scanning Corp. devices

FDA 510(k) Submission Details - K912514

510(k) Number K912514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1991
Decision Date December 16, 1991
Days to Decision 193 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
83d slower than avg
Panel avg: 110d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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 - HJO Biomicroscope, Slit-lamp, Ac-powered

All 79
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K912514.
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