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Phoenix Disposable Pressure Transducer #73-600

by Baxter Healthcare Corp

510(k) K925638

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK925638 Date18 Oct 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1146-2013 FDA Class II initiated 30 Jan 2013 on shared 510(k) K925638

    The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.

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

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  • Withdrawn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
DXO
Device Class
Class II
Regulation
21 CFR Part 870.2870
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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