Cleared Traditional

K853432 - 5.0 IOP & 7.5 IOP PROBES (FDA 510(k) Clearance)

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

K853432 · Diasonics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
176d
Days
Class 2
Risk

K853432 is an FDA 510(k) clearance for the 5.0 IOP & 7.5 IOP PROBES. Classified as Echoencephalograph (product code GXW), Class II - Special Controls.

Submitted by Diasonics, Inc. (Milipitas, US). The FDA issued a Cleared decision on February 7, 1986 after a review of 176 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1240 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diasonics, Inc. devices

Submission Details

510(k) Number K853432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1985
Decision Date February 07, 1986
Days to Decision 176 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 148d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXW Echoencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1240
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 Neurology devices follow this clearance model.