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SIROCCO Thermal Regulating System

by Galmaz Biotech S.L.

510(k) K102856

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 NumberK102856 Date30 Jun 2011ClearedStatusActive

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  • Withdrawn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
DWJ
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 SIROCCO Thermal Regulating System is a device intended to prevent and treat hypothermia and provide warmth to cold or shivering patients. It is a thermal regulating system classified as a Class II medical device under the regulation number 870.5900.

The device is supplied as part of a 510(k) notification with the K number K102856. It is intended for use in conditions that could cause patients to become cold. The device is not described as single-use or reusable, and no specific storage or size information is provided.

Questions

AI-generated answers, 26 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 SIROCCO Thermal Regulating System used for?

    This device is intended to prevent and treat hypothermia and provide warmth to patients who are cold or shivering.

  • What is the regulatory classification of the SIROCCO Thermal Regulating System?

    It is classified as a Class II medical device under regulation number 870.5900.

  • How is the device supplied?

    The device is supplied as part of a 510(k) notification with the K number K102856.

  • Is the SIROCCO Thermal Regulating System intended for single use?

    The device is not described as single-use or reusable, but no specific usage instructions are provided.

  • What is the decision description for the SIROCCO Thermal Regulating System?

    The device was determined to be substantially equivalent to a predicate device.