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R2 Pace Pad, Model 480

by Darox Corp. 510(k)

Active United States

510(k) K895729

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895729 Date12 Oct 1989ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1241-06 FDA Unclassified (pre-2012) initiated 18 May 2006 on shared 510(k) K895729

    The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

510(k)

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

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