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Model #210 Stealth Defib Pads

by Cardiotronics, Inc.

510(k) K904462

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 NumberK904462 Date3 Dec 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  • Withdrawn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
LDD
Device Class
Class II
Regulation
21 CFR Part 870.5300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

Model #210 Stealth Defib Pads are a Class 2 cardiovascular device designed for use with low-energy defibrillators, including paddles. The device is manufactured by Cardiotronics, Inc. and is identified by product code LDD.

The Model #210 Stealth Defib Pads are supplied as a single device and received FDA 510(k) clearance on December 3, 1990, under K-number K904462. The device is regulated under product code LDD and is intended for cardiovascular applications. No information regarding sterility, single-use or reusable status, MRI safety, or storage conditions is provided in the data.

Other devices from Cardiotronics, Inc.

See all devices from Cardiotronics, Inc. →

Questions

AI-generated answers, 28 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 Model #210 Stealth Defib Pads used for?

    The Model #210 Stealth Defib Pads are designed for use with low-energy defibrillators, including paddles, for cardiovascular applications. They are a Class 2 medical device manufactured by Cardiotronics, Inc.

  • What is the regulatory status of the Model #210 Stealth Defib Pads?

    The Model #210 Stealth Defib Pads received FDA 510(k) clearance on December 3, 1990, under K-number K904462. They are regulated under product code LDD and are classified as substantially equivalent to other devices in this category.

  • Is the Model #210 Stealth Defib Pads single-use or reusable?

    The device data does not specify whether the Model #210 Stealth Defib Pads are single-use or reusable. No information regarding sterility or single-use status is provided in the available documentation.

  • What are the specifications of the Model #210 Stealth Defib Pads?

    The Model #210 Stealth Defib Pads are supplied as a single device. The data does not include specific measurements, sizes, or storage conditions. The device is manufactured by Cardiotronics, Inc. and is identified by product code LDD.