Cleared Traditional

K790738 - HABITSABATER

K790738 is an FDA 510(k) clearance for HABITSABATER, manufactured by Jackson Ent.. The device is a Class 2 Neurology device with product code HCB cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K790738 · Jackson Ent. · Neurology device
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Jun 1979
Decision
65d
Days
Class 2
Risk

K790738 is an FDA 510(k) clearance for the HABITSABATER. Classified as Device, Aversive Conditioning (product code HCB), Class II - Special Controls.

Submitted by Jackson Ent. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1979 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K790738

510(k) Number K790738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1979
Decision Date June 20, 1979
Days to Decision 65 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
84d faster than avg
Panel avg: 149d · This submission: 65d
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.

K790738 · HABITSABATER
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