Skip to content

Passport V Monitor, Model 0998-00-6100

by Datascope Corp., Patient Monitoring Division

510(k) K091834

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK091834 Date15 Jul 2009ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1280-2015 FDA Class II initiated 23 Jan 2015

    An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement

    • Terminated Z-1785-2010 FDA Unclassified (pre-2012) initiated 28 Apr 2010

    An issue with the Passport V Monitor has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational.

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  • Withdrawn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
MHX
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Datascope Corp., Patient Monitoring Division