Cleared Traditional

K992874 - Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM

K992874 is an FDA 510(k) clearance for Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT ..., manufactured by Wr Medical Electronics Co.. The device is a Class 2 Physical Medicine device with product code KTB cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K992874 · Wr Medical Electronics Co. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
84d
Days
Class 2
Risk

K992874 is an FDA 510(k) clearance for the Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM. Classified as Device, Iontophoresis, Specific Uses (product code KTB), Class II - Special Controls.

Submitted by Wr Medical Electronics Co. (Stillwater, US). The FDA issued a Cleared decision on November 18, 1999 after a review of 84 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.

View all Wr Medical Electronics Co. devices

FDA 510(k) Submission Details - K992874

510(k) Number K992874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1999
Decision Date November 18, 1999
Days to Decision 84 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
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 9
Devices cleared under the same product code (KTB) and FDA review panel - the closest regulatory comparables to K992874.
RH-900
K031115 · Iomed, Inc. · Jul 2003
TRANSQ3
K001522 · Iomed, Inc. · Oct 2000
PHORESOR MODEL PM2000
K001410 · Iomed, Inc. · Aug 2000
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