Cleared Traditional

K902442 - SUDORMED SWEAT PATCH SPECIMEN CONTAINER

K902442 is an FDA 510(k) clearance for SUDORMED SWEAT PATCH SPECIMEN CONTAINER, manufactured by Sudormed, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K902442 · Sudormed, Inc. · Chemistry device
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Oct 1990
Decision
125d
Days
Class 2
Risk

K902442 is an FDA 510(k) clearance for the SUDORMED SWEAT PATCH SPECIMEN CONTAINER. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Sudormed, Inc. (Lake Forest, US). The FDA issued a Cleared decision on October 4, 1990 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Sudormed, Inc. devices

FDA 510(k) Submission Details - K902442

510(k) Number K902442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1990
Decision Date October 04, 1990
Days to Decision 125 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 88d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 159
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K902442.
NEW-VENT
K911809 · Concord/Portex · Aug 1991
SYRINGE TIP CAP
K911638 · Concord/Portex · Jun 1991
SUPERSERUM REAGENT (SSR)
K910646 · International Technidyne Corp. · May 1991
VACUTAINER PLUS WITH HEMOGARD CLOSURE
K901449 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
VENOJECT II BLOOD COLLECTION TUBES
K900309 · Terumo Medical Corp. · Mar 1990
PUMPETTE(TM)
K884111 · Helena Laboratories · Dec 1988