Cleared Traditional

K882421 - INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE

K882421 is an FDA 510(k) clearance for INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE, manufactured by Dermacare Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JOS cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K882421 · Dermacare Products, Inc. · General & Plastic Surgery device
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Jun 1988
Decision
17d
Days
Class 2
Risk

K882421 is an FDA 510(k) clearance for the INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Dermacare Products, Inc. (Louisville, US). The FDA issued a Cleared decision on June 30, 1988 after a review of 17 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 Dermacare Products, Inc. devices

FDA 510(k) Submission Details - K882421

510(k) Number K882421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1988
Decision Date June 30, 1988
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOS Device Classification - Class 2, Special Controls

Product Code JOS Electrode, 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.

Regulatory Peers - JOS Electrode, Electrosurgical

All 29
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K882421.
MICRO CAUTERY NEEDLES
K891400 · Zinnanti Surgical Instruments, Inc. · Apr 1989
HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE
K890972 · Instrument Makar, Inc. · Mar 1989
STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE
K890973 · Instrument Makar, Inc. · Mar 1989
YESNG PATIENT PLATE #80226
K881144 · Ferguson Medical · Apr 1988
MONOPOLAR CAUTERY BLADE TIP #TM-1701
K873653 · Arthropedics, Inc. · Dec 1987
MONOPOLAR CAUTERY CONICAL TIP #TM-1702
K873654 · Arthropedics, Inc. · Dec 1987