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Sudormed Sweat Patch Specimen Container

by Sudormed, Inc.

510(k) K902442

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902442 Date4 Oct 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sudormed Sweat Patch Specimen Container is a sterile, single-use device classified under product code JKA as a container for collecting and preserving sweat specimens. It is designed to safely store samples obtained from sweat patches used in clinical chemistry applications, ensuring integrity for subsequent analysis.

This device is supplied sterile and intended for single-use in clinical settings. It is regulated under FDA 510(k) clearance (K902442) with a decision of Substantially Equivalent (SESE) and falls under the Clinical Chemistry advisory committee. No additional storage or preparation is required beyond adhering to standard laboratory protocols for sweat specimen handling.

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