VITAL SIGNS MONITOR, PROPAQ LT— 510(k) K033378

Name: FDA 510(k) clearance K033378
Creator: U.S. Food and Drug Administration
Published: 2004-03-01

Substantially Equivalent

Welch Allyn Protocol, Inc.

FDA 510(k) clearance K033378 for VITAL SIGNS MONITOR, PROPAQ LT, Substantially Equivalent on 2004-03-01. Applicant: Welch Allyn Protocol, Inc.. Device class: 2.

Clearance details

Applicant: Welch Allyn Protocol, Inc.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2003-10-22
Decision date: 2004-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MWI

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K260438 — Vital Signs Monitor (CLEO2)2026-08-14
K253417 — Masimo Root Monitoring System2026-08-12
K253196 — Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)2026-06-12
K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

More clearances from Welch Allyn Protocol, Inc.

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K070204 — LINK TO ACUITY CLINICIAN NOTIFIER2007-03-23
K063419 — MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )2006-12-04
K031740 — VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES2003-08-26
K022453 — MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM2002-08-21
K021681 — MICROPAQ, MODELS 402, 4042002-07-23

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K033378

K-number listed on FDA's recall record

Z-0633-2014 — The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.Class II·Terminated·Welch Allyn Protocol, Inc·20131121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033378.

Data sourced from openFDA. This site is unofficial and independent of the FDA.