Cleared Traditional

K920271 - WEINSTEIN CORNEAL MIRCOAESTHESIOMETER

K920271 is an FDA 510(k) clearance for WEINSTEIN CORNEAL MIRCOAESTHESIOMETER, manufactured by Connecticut Bioinstruments, Inc.. The device is a Class 1 Ophthalmic device with product code HJC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K920271 · Connecticut Bioinstruments, Inc. · Ophthalmic device
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Apr 1992
Decision
90d
Days
Class 1
Risk

K920271 is an FDA 510(k) clearance for the WEINSTEIN CORNEAL MIRCOAESTHESIOMETER. Classified as Esthesiometer, Ocular (product code HJC), Class I - General Controls.

Submitted by Connecticut Bioinstruments, Inc. (Danbury, US). The FDA issued a Cleared decision on April 21, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1040 - 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 Connecticut Bioinstruments, Inc. devices

FDA 510(k) Submission Details - K920271

510(k) Number K920271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1992
Decision Date April 21, 1992
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

HJC Device Classification - Class 1, General Controls

Product Code HJC Esthesiometer, Ocular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1040
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.