Cleared Traditional

K082204 - SERIES SY DISPOSABLE ELECTROSURGICAL PAD (FDA 510(k) Clearance)

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

K082204 · Ventlab Corp. · General & Plastic Surgery device
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Aug 2008
Decision
8d
Days
Class 2
Risk

K082204 is an FDA 510(k) clearance for the SERIES SY DISPOSABLE ELECTROSURGICAL PAD. Classified as Electrosurgical Patient Return Electrode (product code ODR), Class II - Special Controls.

Submitted by Ventlab Corp. (Crofton, US). The FDA issued a Cleared decision on August 13, 2008 after a review of 8 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 Ventlab Corp. devices

Submission Details

510(k) Number K082204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2008
Decision Date August 13, 2008
Days to Decision 8 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 114d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code ODR Electrosurgical Patient Return Electrode
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Ground Pad Used To Finish Circuit During Electrosurgery. A Single Use, Non-sterile Dispersive Electrode With A Pre-attached Cord Used To Adhere To The Patient Over The Entire Pad Surface To Complete The Electrosurgical Circuit Between The Generator, The Active Electrode, And The Patient.
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.