Skip to content

Vital Signs Monitor, Propaq Lt

by Welch Allyn Protocol, Inc.

510(k) K033378

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK033378 Date1 Mar 2004ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0633-2014 FDA Class II initiated 21 Nov 2013

    Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.

  • 2 recalls, same reason

    • Terminated Z-0215-2007 FDA Unclassified (pre-2012) initiated 22 Oct 2006
    • Terminated Z-0216-2007 FDA Unclassified (pre-2012) initiated 22 Oct 2006

    Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.

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  • Withdrawn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
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Welch Allyn Protocol, Inc.