Cleared Traditional

K801153 - VALLEYLAB RETURN ELECTRODE MONITOR

K801153 is an FDA 510(k) clearance for VALLEYLAB RETURN ELECTRODE MONITOR, manufactured by Valleylab, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K801153 · Valleylab, Inc. · General & Plastic Surgery device
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May 1980
Decision
6d
Days
Class 2
Risk

K801153 is an FDA 510(k) clearance for the VALLEYLAB RETURN ELECTRODE MONITOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Valleylab, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980 after a review of 6 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 Valleylab, Inc. devices

FDA 510(k) Submission Details - K801153

510(k) Number K801153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1980
Decision Date May 20, 1980
Days to Decision 6 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 115d · This submission: 6d
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 1192
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K801153.
WATER RESISTANT FOOTSWITCH W/CABLE
K810101 · Aspen Laboratories, Inc. · Jan 1981
BOUIE ELECTROSURGICAL TIP CLEANER
K802827 · Sybron Corp. · Dec 1980
ELECTRO SURGICAL TIP CLEANER
K802605 · Concept, Inc. · Nov 1980
REUSABLE HAND-TROL
K800597 · Aspen Laboratories, Inc. · Apr 1980
DIATHERMIC SNARE (CRESENT TYPE)
K792343 · Mill-Rose Laboratory · Dec 1979
A.D.E. ASPEN DISPERSIVE ELECTRODE
K792315 · Zimmer, Inc. · Nov 1979