Cleared Traditional

NEW ENGLAND MEDICAL GROUNDING PAD (K931982) - FDA 510(k) Clearance

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

K931982 · New England Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
166d
Days
Class 2
Risk

K931982 is an FDA 510(k) clearance for the NEW ENGLAND MEDICAL GROUNDING 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 New England Medical, Inc. (Plainville, US). The FDA issued a Cleared decision on October 5, 1993 after a review of 166 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all New England Medical, Inc. devices

Submission Details

510(k) Number K931982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1993
Decision Date October 05, 1993
Days to Decision 166 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 115d · This submission: 166d
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 601
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K931982.
ENDOPATH ENDOSCOPIC ELECTROSURGICAL FORCEPS WITH CUTTING FEATURE
K934784 · Ethicon, Inc. · Mar 1994
ELECTROSURGIAL INSTRUMENTS
K932654 · Medline Industries, Inc. · Feb 1994
ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD
K934985 · KARL STORZ Endoscopy-America, Inc. · Feb 1994
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
K922576 · Aesculap, Inc. · Jun 1993
MODELS UES-10 & PSD-10
K911904 · Olympus Corp. · Jul 1991
WECK ELECTROSURGICAL GENERATOR #174200
K902232 · Edward Weck, Inc. · Aug 1990