510(k) · Cleared
Recalled · Class II · 2013Vital Signs Monitor, Propaq LT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn Protocol, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Mar 1, 2004 as substantially equivalent to K951246 (Protocol Systems, Inc., 1996) and 5 other predicates after a 131-day review. Its family tree reaches back 7 generations to 1997. 108 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 1, 2004
- Review
- 131 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 3
- Predicates
- 6
Its longest line of descent runs back 7 generations to K962603 (1997). 18 ancestors in all, the oldest K904039 (1990). 108 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 2 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 1 generation backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- This deviceK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004
- Descendant · cites it directly · 65 of its ownK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- Descendant · 2 generations on · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- Descendant · 3 generations on · 51 of its ownK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- Descendant · 4 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- Descendant · 4 generations on · 24 of its ownK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
Showing 5 of 108 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 108 · See all- K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012 · cites it directly65descendants
- K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · 2 generations on58descendants
- K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014 · 3 generations on51descendants
- K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 4 generations on24descendants
- K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −2 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −1 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| 0 (this device) | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | — |
| +1 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| +2 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| +3 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| +4 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| +4 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 11 | 0 |
| 2023 | 9 | 0 |
| 2024 | 11 | 0 |
| 2025 | 13 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951246 | Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography OptionsSummary page 1…tion: Class II Predicate Devices The predicate devices for the Propaq LT 802 Series monitors are: · Welch Allyn Protocol, Propaq Encore Model 2XX Series, K951246, K01 2451, • Welch Allyn Protocol, VSM Model 5300, K021681, K031740 · Welch Allyn Protocol, Micropaq Mode… | 1996 |
| * | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Summary page 1…ss II Predicate Devices The predicate devices for the Propaq LT 802 Series monitors are: · Welch Allyn Protocol, Propaq Encore Model 2XX Series, K951246, K01 2451, • Welch Allyn Protocol, VSM Model 5300, K021681, K031740 · Welch Allyn Protocol, Micropaq Model 402/404,… | 2001 |
| * | K021681 | Micropaq, Models 402, 404Summary page 1…aq LT 802 Series monitors are: · Welch Allyn Protocol, Propaq Encore Model 2XX Series, K951246, K01 2451, • Welch Allyn Protocol, VSM Model 5300, K021681, K031740 · Welch Allyn Protocol, Micropaq Model 402/404, K002725 · Nellcor Puritan Bennett Pulse Oximeter… | 2002 |
| * | K031740 | VSM - Vital Signs Monitor, Model 53000 SeriesSummary page 1…Series monitors are: · Welch Allyn Protocol, Propaq Encore Model 2XX Series, K951246, K01 2451, • Welch Allyn Protocol, VSM Model 5300, K021681, K031740 · Welch Allyn Protocol, Micropaq Model 402/404, K002725 · Nellcor Puritan Bennett Pulse Oximeter Model N-… | 2003 |
| * | K002725 | Micropaq, Models 402 and 404Summary page 1…ore Model 2XX Series, K951246, K01 2451, • Welch Allyn Protocol, VSM Model 5300, K021681, K031740 · Welch Allyn Protocol, Micropaq Model 402/404, K002725 · Nellcor Puritan Bennett Pulse Oximeter Model N-550, K021090 Device Description The Propaq LT 802 Series of moni… | 2000 |
| * | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterSummary page 1…l, VSM Model 5300, K021681, K031740 · Welch Allyn Protocol, Micropaq Model 402/404, K002725 · Nellcor Puritan Bennett Pulse Oximeter Model N-550, K021090 Device Description The Propaq LT 802 Series of monitors are small, lightweight patient monitoring devices intended to be us… | 2002 |
What descends from it? (108)
See all 1086 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121013 | Connex Vital Signs Monitor 6000 Series | 2012 | 65 |
| K122036 | Visi Mobile Monitoring System | 2012 | 20 |
| K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0 | 2010 | 17 |
| K110015 | Vitalsens, Aingeal, V-Pod | 2011 | 4 |
| K051375 | Vital Signs Monitor | 2005 | 3 |
| K132407 | Vital Signs Patch System (in Short VSP) | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2013 | Class II | Z-0633-2014 | Device Design | 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… |
| Oct 22, 2006 | Not classified | Z-0216-2007 | Other | 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 | Other | Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K121013 (Welch Allyn, Inc., 2012) has gone furthest, with 65 descendants of its own.
- 4 other devices also cite its predicate K951246.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
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…
Read the full statement (127 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033378 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033378: Vital Signs Monitor, Propaq LT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033378
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026