510(k) · Cleared
ClearedPropaq 200 Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Protocol Systems, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on May 10, 1995 after a 208-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 282 devices in its family, counting itself, has a Class I recall. 281 later devices descend from it.
- Decided
- May 10, 1995
- Review
- 208 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 0
281 later devices descend from it, 1 citing it directly. 1 of the 282 devices in this family, counting this one, has a Class I recall.
- This deviceK945071 Propaq 200 MonitorProtocol Systems, Inc. · 1995
- Descendant · cites it directly · 280 of its ownK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- Descendant · 2 generations on · 114 of its ownK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- Descendant · 2 generations on · 108 of its ownK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- Descendant · 2 generations on · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
Showing 5 of 281 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093261 MOVES2 generations on · 2010
Most influential descendants
Showing 5 of 281 · See all- K012451Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001 · cites it directly280descendants
- K032363Zoll M Series Nibp OptionZoll Medical Corp · 2003 · 2 generations on114descendants
- K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · 2 generations on108descendants
- K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · 2 generations on99descendants
- K113054EquivitalHidalgo Limited · 2012 · 2 generations on71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945071 | Propaq 200 Monitor | Protocol Systems, Inc. | 1995 | — |
| +1 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| +2 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| +2 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| +2 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| +2 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (281)
See all 2811 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | 2001 | 280 |
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 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K012451 (Welch Allyn Protocol, Inc., 2001) has gone furthest, with 280 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 | — |
https://510kreport.com/device/K945071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K945071: Propaq 200 Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945071
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026