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STAT-PAD

by Cardiac Resucitator Corp.

510(k) K871538

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 NumberK871538 Date24 Jun 1987ClearedStatusActive

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  • Withdrawn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
Stat-Pad (Tm)
510(k) Number
FDA Product Code
DRO
Device Class
Class II
Regulation
21 CFR Part 870.5550
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

STAT-PAD is a pacemaker, cardiac, external transcutaneous (non-invasive) device. It is designed to provide cardiac pacing through the skin without invasive procedures.

The device is manufactured by Cardiac Resuscitator Corp. and is authorized under FDA 510(k) clearance K871538 with a product code of DRO. It is a Class II device and is not specified as single-use or reusable in the provided data.

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