Cleared Traditional

K011842 - SABRE COMPAC

K011842 is an FDA 510(k) clearance for SABRE COMPAC, manufactured by Sle Limited. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K011842 · Sle Limited · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
210d
Days
Class 2
Risk

K011842 is an FDA 510(k) clearance for the SABRE COMPAC. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Sle Limited (La Jolla, US). The FDA issued a Cleared decision on January 8, 2002 after a review of 210 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - 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.

FDA 510(k) Submission Details - K011842

510(k) Number K011842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2001
Decision Date January 08, 2002
Days to Decision 210 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 149d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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 - GWJ Stimulator, Auditory, Evoked Response

All 75
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K011842.
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K021895 · Bio-Logic Systems Corp. · Jul 2002
ECHO-SCREEN T, TA, TD, TDA, TC
K013977 · Fischer-Zoth Audiologic Systems, Inc. · Jun 2002
BIO-LOGIC ABAER CUB
K021215 · Bio-Logic Systems Corp. · May 2002
AURIS AEP
K012415 · Synapsys, Inc. · Dec 2001
ALGO 3 NEWBORN HEARING SCREENER
K013137 · Natus Medical, Inc. · Oct 2001
MB 11
K011746 · Maico Diagnostic GmbH · Aug 2001
K011842 · SABRE COMPAC
Download PDF FDA Summary Sle Limited