# K033378: Vital Signs Monitor, Propaq LT

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn Protocol, Inc.
- Decided: Mar 1, 2004 after 131 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962603 (1997). 18 ancestors in all.
108 later devices descend from it; 6 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951246: Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options, Protocol Systems, Inc. (1996) Summary page 1.
- K012451: Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246, Welch Allyn Protocol, Inc. (2001) Summary page 1.
- K021681: Micropaq, Models 402, 404, Welch Allyn Protocol, Inc. (2002) Summary page 1.
- K031740: VSM - Vital Signs Monitor, Model 53000 Series, Welch Allyn Protocol, Inc. (2003) Summary page 1.
- K002725: Micropaq, Models 402 and 404, Protocol Systems, Inc. (2000) Summary page 1.
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2002) Summary page 1.

## Most influential descendants
- K121013: Connex Vital Signs Monitor 6000 Series (2012), 65 descendants of its own
- K140188: Masimo Root Monitoring System (2014), 58 descendants of its own
- K142394: Masimo Root Monitoring System and Accesories (2014), 51 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K150314: Masimo MightySat Rx Fingertip Pulse Oximeter (2015), 24 descendants of its own

## Recalls of this device
- Nov 21, 2013 · Class II · Z-0633-2014: 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 
- Oct 22, 2006 · Not classified · Z-0216-2007: Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.
- Oct 22, 2006 · Not classified · Z-0215-2007: Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.

## Indications for use
The Propaq LT 802 series monitors are highly portable devices intended to be used by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of ambulatory and non-ambulatory neonate, pediatric and adult patients. These monitors are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by this device are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services and other healthcare applications. The monitors may be used as standalone devices or as devices networked to an Acuity r central station through wireless communication over Welch Allyn's FlexNet T M network. This device is available for sale only upon the order of a physician or licensed health care professional.

Source page: https://510kreport.com/device/K033378
Methodology: https://510kreport.com/methodology