Cleared Traditional

K820902 - MULTIPERFECTEMP

K820902 is an FDA 510(k) clearance for MULTIPERFECTEMP, manufactured by Kay Medical, 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.

K820902 · Kay Medical, Inc. · General & Plastic Surgery device
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Apr 1982
Decision
26d
Days
Class 2
Risk

K820902 is an FDA 510(k) clearance for the MULTIPERFECTEMP. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Kay Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1982 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 Kay Medical, Inc. devices

FDA 510(k) Submission Details - K820902

510(k) Number K820902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1982
Decision Date April 26, 1982
Days to Decision 26 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
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 2015
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K820902.
BALL TIP COAGULATING ELECTRODES
K822062 · American Endoscopy, Inc. · Aug 1982
DESERET CAPACITY PLUS ELECTROSURG. PAD
K821356 · Warner-Lambert Co. · Jul 1982
DIATHERMIC HANDLE FOR BIOPSY FORCEPS
K820971 · Mill-Rose Laboratory · Apr 1982
HOT BIOPSY FORCEPS W/ROUND CUPS
K820983 · Mill-Rose Laboratory · Apr 1982
SYBRON BOVIE CSV HAND CONTR. ELECTROSURG
K820494 · Sybron Corp. · Apr 1982
BALLARD MEDICAL PRODUCTS ELECTRO-SURG
K820713 · Ballard Medical Products · Mar 1982