Cleared Traditional

K821736 - ECHO-PULSE KM555

K821736 is an FDA 510(k) clearance for ECHO-PULSE KM555, manufactured by Rabar, Inc.. The device is a Class 2 Neurology device with product code GXW cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K821736 · Rabar, Inc. · Neurology device
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Dec 1982
Decision
178d
Days
Class 2
Risk

K821736 is an FDA 510(k) clearance for the ECHO-PULSE KM555. Classified as Echoencephalograph (product code GXW), Class II - Special Controls.

Submitted by Rabar, Inc. (Rochester, US). The FDA issued a Cleared decision on December 9, 1982 after a review of 178 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 Rabar, Inc. devices

FDA 510(k) Submission Details - K821736

510(k) Number K821736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1982
Decision Date December 09, 1982
Days to Decision 178 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 148d · This submission: 178d
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 K821736.
SMS-712NA
K903085 · Toshiba America Medical Systems, In.C · Oct 1990
5.0 IOP & 7.5 IOP PROBES
K853432 · Diasonics, Inc. · Feb 1986
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