510(k) · Cleared
ClearedPropaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn Protocol, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Aug 20, 2001 as substantially equivalent to K945071 (Protocol Systems, Inc., 1995) and 3 other predicates after a 19-day review. Its family tree reaches back 4 generations to 1997. 1 of the 289 devices in its family, counting itself, has a Class I recall. 280 later devices descend from it.
- Decided
- Aug 20, 2001
- Review
- 19 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K962603 (1997). 8 ancestors in all, the oldest K945071 (1995). 280 later devices descend from it, 13 citing it directly. 1 of the 289 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 1 generation backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- This deviceK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- Descendant · cites it directly · 114 of its ownK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- Descendant · cites it directly · 108 of its ownK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- Descendant · cites it directly · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- Descendant · cites it directly · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
- Descendant · 2 generations on · 70 of its ownK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
Showing 5 of 280 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093261 MOVEScites it directly · 2010
Most influential descendants
Showing 5 of 280 · See all- K032363Zoll M Series Nibp OptionZoll Medical Corp · 2003 · cites it directly114descendants
- K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · cites it directly108descendants
- K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · cites it directly99descendants
- K113054EquivitalHidalgo Limited · 2012 · cites it directly71descendants
- K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc. · 2014 · 2 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −1 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| 0 (this device) | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| +1 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| +1 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| +1 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| +1 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| +2 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 8 | 1 |
| 2011 | 11 | 0 |
| 2012 | 12 | 0 |
| 2013 | 9 | 0 |
| 2014 | 17 | 0 |
| 2015 | 15 | 0 |
| 2016 | 10 | 0 |
| 2017 | 15 | 0 |
| 2018 | 15 | 0 |
| 2019 | 19 | 0 |
| 2020 | 20 | 0 |
| 2021 | 8 | 0 |
| 2022 | 19 | 0 |
| 2023 | 20 | 0 |
| 2024 | 21 | 0 |
| 2025 | 25 | 0 |
| 2026 | 13 | 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.
1 device in this family has a Class I recall. 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K945071 | Propaq 200 MonitorSummary page 1…Classification: Class II Predicate Device The predicate device for the Propaq 200 Series Monitors is the Propaq 200 Series cleared for market under 510(k) submissions K945071 and K951246, except for the improved SpO, Channel. The predicate device for the improved SpO Channel in the Propaq 200 Series is… | 1995 |
| * | K951246 | Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography OptionsSummary page 1…ion: Class II Predicate Device The predicate device for the Propaq 200 Series Monitors is the Propaq 200 Series cleared for market under 510(k) submissions K945071 and K951246, except for the improved SpO, Channel. The predicate device for the improved SpO Channel in the Propaq 200 Series is the Nellcor… | 1996 |
| * | K991823 | N-395 Pulse Oximeter, Model N-395Summary page 2…hannel is substantially equivalent to the SpO; channel in the Nellcor model N-395 Pulse Oximeter. The Nellcor model N-395 was cleared for market under 510(k) submissions K991823 and K993637. Summary of Performance Testing The Propaq 200 Series monitors and associated accessories have been tested and found… | 1999 |
| * | K993637 | N-395 Pulse Oximeter, with Extended Device ClaimsSummary page 1…predicate device for the improved SpO Channel in the Propaq 200 Series is the Nellcor model N-395 Pulse Oximeter cleared for market under 510(k) submissions K951246 and K993637. Device Description The Propaq 200 Series monitors are small, light weight, portable, multi-parameter patient monitors equipped… | 1999 |
What descends from it? (280)
See all 28013 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032363 | Zoll M Series Nibp Option | 2003 | 114 |
| K033378 | Vital Signs Monitor, Propaq LT | 2004 | 108 |
| K061993 | Equivital, Model EQ-01 | 2006 | 99 |
| K113054 | Equivital | 2012 | 71 |
| K081140 | Visensia | 2008 | 22 |
| K100654 | Zoll Propaq MD | 2010 | 11 |
| K053112 | Biosign | 2006 | 8 |
| K093261 | MOVES Class I | 2010 | 7 |
| K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100 | 2009 | 7 |
| K130773 | Tempus Pro Patient Monitor | 2013 | 6 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093261MOVESThornhill Research, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 4 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K032363 (Zoll Medical Corp, 2003) has gone furthest, with 114 descendants of its own.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
The Propaq 200 Series monitors are intended to be used by skilled clinicians for multiparameter vital signs monitoring of neonatal, pediatric, and adult patients in health care facility bedside applications; as well as for intrafacility and interfacility transport.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012451: Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012451
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026