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Quantix/Or Device

by Cardiosonix, Ltd.

510(k) K030357

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030357 Date20 Aug 2003ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0701-05 FDA Unclassified (pre-2012) initiated 13 Dec 2004
    • Terminated Z-0700-05 FDA Unclassified (pre-2012) initiated 13 Dec 2004

    The probe's faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.

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  • Withdrawn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
DPW
Device Class
Class II
Regulation
21 CFR Part 870.2100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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