Cleared Traditional

K853973 - WESCOR MODEL 3700 WEBSTER SWEAT INDUCER

K853973 is an FDA 510(k) clearance for WESCOR MODEL 3700 WEBSTER SWEAT INDUCER, manufactured by Wescor, Inc.. The device is a Class 2 Physical Medicine device with product code KTB cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K853973 · Wescor, Inc. · Physical Medicine device
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Oct 1985
Decision
20d
Days
Class 2
Risk

K853973 is an FDA 510(k) clearance for the WESCOR MODEL 3700 WEBSTER SWEAT INDUCER. Classified as Device, Iontophoresis, Specific Uses (product code KTB), Class II - Special Controls.

Submitted by Wescor, Inc. (Logan, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - the FDA physical medicine 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.

FDA 510(k) Submission Details - K853973

510(k) Number K853973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1985
Decision Date October 16, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 116d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTB Device Classification - Class 2, Special Controls

Product Code KTB Device, Iontophoresis, Specific Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - KTB Device, Iontophoresis, Specific Uses

All 15
Devices cleared under the same product code (KTB) and FDA review panel - the closest regulatory comparables to K853973.
PHORESOR II, MODEL PM900
K974855 · Iomed, Inc. · Mar 1998
TRANSQ ELECTRODE PHORESOR II
K954126 · Iomed, Inc. · Jan 1996
CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM
K895775 · Medtronic Vascular · Apr 1990
SYS MACRODUCT SWEAT COLLECTION SYS 3600
K840472 · Wescor, Inc. · Mar 1984
IONOPHORELIC SWEAT STIM. CHLORIDE-
K832059 · Medtronic Vascular · Aug 1983
ELECTROAPPLICATOR MODEL C-1
K790205 · Mcg, Inc. · Mar 1979
K853973 · WESCOR MODEL 3700 WEBSTER SWEAT INDUCER
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