Cleared Traditional

K781105 - TONOMETER, DIGITON

K781105 is an FDA 510(k) clearance for TONOMETER, manufactured by Ical, Inc.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K781105 · Ical, Inc. · Ophthalmic device
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Sep 1978
Decision
86d
Days
Class 2
Risk

K781105 is an FDA 510(k) clearance for the TONOMETER, DIGITON. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Ical, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978 after a review of 86 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.

FDA 510(k) Submission Details - K781105

510(k) Number K781105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date September 27, 1978
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 110d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKY Device Classification - Class 2, Special Controls

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.

K781105 · TONOMETER, DIGITON
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