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SCD Therapeutic Stocking System

by Kendall Healthcare Products Co. Div.Of Tyco Health

510(k) K902497

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 NumberK902497 Date15 Aug 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  • Withdrawn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
DWL
Device Class
Class II
Regulation
21 CFR Part 880.5780
Advisory Committee
General Hospital
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 SCD Therapeutic Stocking System is a medical support stocking designed to prevent pooling of blood in the legs. It is classified as a Class II device under FDA regulation number 880.5780 and is identified by the product code DWL.

The system received FDA 510(k) clearance (K902497) on August 15, 1990, and is manufactured by Kendall Healthcare Products Co., a division of Tyco Health. It is supplied as a non-sterile, reusable device intended for use in general hospital settings.

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Questions

AI-generated answers, 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.

  • What is the SCD Therapeutic Stocking System intended to do?

    The SCD Therapeutic Stocking System is designed to prevent pooling of blood in the legs, as stated in the device description. It functions as a medical support stocking for this purpose in general hospital settings.

  • Is the SCD Therapeutic Stocking System sterile or non-sterile when supplied?

    The device is supplied as a non-sterile product, as explicitly stated in the description under specifications. It is not provided in a sterile condition and requires appropriate handling prior to use.

  • Can the SCD Therapeutic Stocking System be reused, or is it single-use?

    The SCD Therapeutic Stocking System is classified as a reusable device, as indicated in the description. It is intended for multiple uses in general hospital environments, not for single-use disposal.

  • What regulatory pathway was used for the SCD Therapeutic Stocking System?

    The device received FDA 510(k) clearance via the traditional pathway, as shown by the clearance_type field and the K902497 number. It was found substantially equivalent to a predicate device, leading to its Class II classification.

  • What is the product code and regulation number for the SCD Therapeutic Stocking System?

    The product code is DWL and the regulation number is 880.5780, both directly from the device data. These identifiers classify it as a medical support stocking under FDA regulations for general hospital use.