Cleared Traditional

K895775 - CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM

K895775 is an FDA 510(k) clearance for CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM, manufactured by Medtronic Vascular. The device is a Class 2 Physical Medicine device with product code KTB cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K895775 · Medtronic Vascular · Physical Medicine device
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Apr 1990
Decision
208d
Days
Class 2
Risk

K895775 is an FDA 510(k) clearance for the CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM. Classified as Device, Iontophoresis, Specific Uses (product code KTB), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on April 23, 1990 after a review of 208 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K895775

510(k) Number K895775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1989
Decision Date April 23, 1990
Days to Decision 208 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 116d · This submission: 208d
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 K895775.
Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
K992874 · Wr Medical Electronics Co. · Nov 1999
PHORESOR II, MODEL PM900
K974855 · Iomed, Inc. · Mar 1998
TRANSQ ELECTRODE PHORESOR II
K954126 · Iomed, Inc. · Jan 1996
WESCOR MODEL 3700 WEBSTER SWEAT INDUCER
K853973 · Wescor, Inc. · Oct 1985
SYS MACRODUCT SWEAT COLLECTION SYS 3600
K840472 · Wescor, Inc. · Mar 1984
IONOPHORELIC SWEAT STIM. CHLORIDE-
K832059 · Medtronic Vascular · Aug 1983
K895775 · CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM
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