Cleared Traditional

K031285 - MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD

K031285 is an FDA 510(k) clearance for MEGA 2000 SOFT DUAL CORD PATIENT RETURN..., manufactured by Megadyne Medical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K031285 · Megadyne Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
26d
Days
Class 2
Risk

K031285 is an FDA 510(k) clearance for the MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Megadyne Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 19, 2003 after a review of 26 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 Megadyne Medical Products, Inc. devices

FDA 510(k) Submission Details - K031285

510(k) Number K031285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2003
Decision Date May 19, 2003
Days to Decision 26 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

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 1768
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K031285.
SAPHYRE BIPOLAR ABLATION PROBES
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THERMACOOL TC SYSTEM
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ARTHROCARE PERCD SPINEWAND
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SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES
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RADIONICS SINGLE USE GROUND PAD (DGP-HP)
K030697 · Radionics, Inc. · Apr 2003