Cleared Traditional

ADULT TDS ELECTROSURGICAL GROUNDING PAD (R.E.M.) (K861139) - FDA 510(k) Clearance

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

K861139 · Conmedcorp · General & Plastic Surgery device
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May 1986
Decision
44d
Days
Class 2
Risk

K861139 is an FDA 510(k) clearance for the ADULT TDS ELECTROSURGICAL GROUNDING PAD (R.E.M.). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on May 9, 1986 after a review of 44 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 Conmedcorp devices

Submission Details

510(k) Number K861139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1986
Decision Date May 09, 1986
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 700
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K861139.
EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE
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K874775 · C.R. Bard, Inc. · Feb 1988
ELECTRO-SURGICAL PENCILS
K861742 · Stryker Corp. · Jul 1986
CODMAN DISPOSABLE BIPOLAR CARD
K851487 · Codman & Shurtleff, Inc. · May 1985
RADIOTOM 804
K844428 · Siemens Medical Solutions USA, Inc. · Feb 1985
3M SCOTCHPLATE II DISPERSIVE ELECTRODE
K833364 · 3M Company · Nov 1983