Cleared Traditional

K945531 - BLADE ELECTRODE

K945531 is an FDA 510(k) clearance for BLADE ELECTRODE, manufactured by E & M Engineering, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K945531 · E & M Engineering, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
88d
Days
Class 2
Risk

K945531 is an FDA 510(k) clearance for the BLADE ELECTRODE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by E & M Engineering, Inc. (Richmond, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 88 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 E & M Engineering, Inc. devices

FDA 510(k) Submission Details - K945531

510(k) Number K945531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date February 10, 1995
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 1529
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K945531.
REUSABLE MONOPOLAR FORCEPS
K950877 · Boston Surgical Products, Inc. · Mar 1995
NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS
K950507 · American Hydro-Surgical Instruments, Inc. · Mar 1995
NEZHAT-DORSEY BIPOLAR ELECTROSURGICAL FORCEPS, SURFACE ELECTRODES, AND CORDS
K945694 · American Hydro-Surgical Instruments, Inc. · Feb 1995
VALLEYLAB COATED ELECTRODES
K950188 · Valleylab, Inc. · Feb 1995
NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIES
K945317 · American Hydro-Surgical Instruments, Inc. · Feb 1995
HIGH TEMPERATURE CAUTERY
K945492 · Aaron Medical Industries · Jan 1995