Cleared Traditional

K853291 - GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853291 · Bio-Detek, Inc. · General & Plastic Surgery device
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Oct 1985
Decision
66d
Days
Class 2
Risk

K853291 is an FDA 510(k) clearance for the GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300. Classified as Apparatus, Electrosurgical (product code HAM), Class II - Special Controls.

Submitted by Bio-Detek, Inc. (Mansfield, US). The FDA issued a Cleared decision on October 10, 1985 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 Bio-Detek, Inc. devices

Submission Details

510(k) Number K853291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date October 10, 1985
Days to Decision 66 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 114d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAM Apparatus, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 General & Plastic Surgery devices follow this clearance model.