Cleared Traditional

K853432 - 5.0 IOP & 7.5 IOP PROBES

K853432 is an FDA 510(k) clearance for 5.0 IOP & 7.5 IOP PROBES, manufactured by Diasonics, Inc.. The device is a Class 2 Neurology device with product code GXW cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K853432 · Diasonics, Inc. · Neurology device
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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

FDA 510(k) Submission Details - K853432

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
Combination Product No
PCCP Authorized No
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.

GXW Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GXW Echoencephalograph

Devices cleared under the same product code (GXW) and FDA review panel - the closest regulatory comparables to K853432.
SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS
K921863 · Hewlett-Packard Co. · Sep 1992
SMS-712NA
K903085 · Toshiba America Medical Systems, In.C · Oct 1990
NEURO SECTOR FIXATION DEVICE
K833522 · Advanced Technology Laboratories, Inc. · May 1984
ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000
K770788 · Storz Instrument Co. · May 1977
ECHOENCEPHALOGRAPH, DIGITAL, 1000
K770575 · Storz Instrument Co. · Apr 1977