Cleared Traditional

PASCAL DYNAMIC CONTOUR TONOMETER (K032967) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032967 · Smt Swiss Microtechnology AG · Ophthalmic device
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Nov 2003
Decision
52d
Days
Class 2
Risk

K032967 is an FDA 510(k) clearance for the PASCAL DYNAMIC CONTOUR TONOMETER. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Smt Swiss Microtechnology AG (Littleton, US). The FDA issued a Cleared decision on November 14, 2003 after a review of 52 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 Smt Swiss Microtechnology AG devices

Submission Details

510(k) Number K032967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2003
Decision Date November 14, 2003
Days to Decision 52 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
58d faster than avg
Panel avg: 110d · This submission: 52d
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 55
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K032967.
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iCare HOME2
K211355 · Icare Finland OY · Jan 2022