Cleared Traditional

K802152 - PMT DEPTHALON DEPTH #2102

K802152 is an FDA 510(k) clearance for PMT DEPTHALON DEPTH #2102, manufactured by Progress Mankind Technology. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K802152 · Progress Mankind Technology · Neurology device
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Nov 1980
Decision
72d
Days
Class 2
Risk

K802152 is an FDA 510(k) clearance for the PMT DEPTHALON DEPTH #2102. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Progress Mankind Technology (Hopkins, US). The FDA issued a Cleared decision on November 19, 1980 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - 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.

View all Progress Mankind Technology devices

FDA 510(k) Submission Details - K802152

510(k) Number K802152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1980
Decision Date November 19, 1980
Days to Decision 72 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
76d faster than avg
Panel avg: 148d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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 - GZL Electrode, Depth

All 30
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K802152.
AD-TECH'S DEPTH ELECTRODE
K891920 · Ad-Tech Medical Instrument Corp · Jul 1989
WYLER SPHENOIDAL ELECTRODE
K861031 · Ad-Tech Medical Instrument Corp · Aug 1986
PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC
K802151 · Progress Mankind Technology · Nov 1980
MICROLET FAMILY OF NEEDLE/DEPTH ELECT-
K802249 · Progress Mankind Technology · Nov 1980