Cleared Traditional

K853178 - SIBIS SELF INJURIOUS BEHAVIOR INHIBITIN...

K853178 is an FDA 510(k) clearance for SIBIS SELF INJURIOUS BEHAVIOR INHIBITIN..., manufactured by Oxford Medilog, Inc.. The device is a Class 2 Neurology device with product code HCB cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K853178 · Oxford Medilog, Inc. · Neurology device
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Feb 1986
Decision
213d
Days
Class 2
Risk

K853178 is an FDA 510(k) clearance for the SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM. Classified as Device, Aversive Conditioning (product code HCB), Class II - Special Controls.

Submitted by Oxford Medilog, Inc. (Clearwater, US). The FDA issued a Cleared decision on February 28, 1986 after a review of 213 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5235 - 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 Oxford Medilog, Inc. devices

FDA 510(k) Submission Details - K853178

510(k) Number K853178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date February 28, 1986
Days to Decision 213 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
65d slower than avg
Panel avg: 148d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCB Device Classification - Class 2, Special Controls

Product Code HCB Device, Aversive Conditioning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5235
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.