Cleared Traditional

MODEL 30 CLASSIC PNEUMATONOMETER (K002395) - FDA 510(k) Clearance

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

K002395 · Xomed, Inc. · Ophthalmic device
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Dec 2000
Decision
126d
Days
Class 2
Risk

K002395 is an FDA 510(k) clearance for the MODEL 30 CLASSIC PNEUMATONOMETER. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on December 11, 2000 after a review of 126 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 Xomed, Inc. devices

Submission Details

510(k) Number K002395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2000
Decision Date December 11, 2000
Days to Decision 126 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 110d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
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