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Proguardii Blood Collection Device

by Care Medical Devices, Inc.

510(k) K913914

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 NumberK913914 Date8 Oct 1991ClearedStatusActive

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  • Withdrawn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)

Full name
Proguardii(Tm) Blood Collection Device
510(k) Number
FDA Product Code
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
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 Proguardii Blood Collection Device is a medical device used for blood collection. It is classified under the product code FMI.

The device is supplied by Care Medical Devices, Inc. and has received FDA 510K clearance, with the clearance type being Traditional and the decision description being Substantially Equivalent. The device has the k number K913914 and was cleared on October 8, 1991.

Other devices from Care Medical Devices, Inc.

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 Proguardii Blood Collection Device used for?

    The Proguardii Blood Collection Device is used for blood collection, providing a means to collect blood samples for medical testing and analysis.

  • How is the Proguardii Blood Collection Device supplied?

    The device is supplied by Care Medical Devices, Inc., the manufacturer, and is available for use in medical settings.

  • What is the regulatory status of the Proguardii Blood Collection Device?

    The device has received FDA 510K clearance, with a clearance type of Traditional and a decision description of Substantially Equivalent, indicating that it is substantially equivalent to a predicate device.