510(k) Report

510(k) · Cleared

Cleared

Propaq 102,104,106,102EL,104EL,&106EL

K914838510(k) TraditionalCleared Jan 10, 199277-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Protocol Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Jan 10, 1992 after a 77-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 of the 449 devices in its family, counting itself, have a Class I recall. 448 later devices descend from it.

Decided
Jan 10, 1992
Review
77 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

448 later devices descend from it, 3 citing it directly. 3 of the 449 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1998: 3 descendants cleared2010: 14 descendants cleared1999: 1 descendant cleared2013: 31 descendants cleared, 1 with a Class I recall12011: 17 descendants cleared2009: 15 descendants cleared2004: 8 descendants cleared2007: 8 descendants cleared2003: 2 descendants cleared2014: 26 descendants cleared, 2 with a Class I recall22015: 20 descendants cleared2017: 24 descendants cleared2005: 5 descendants cleared2024: 26 descendants cleared2016: 19 descendants cleared2018: 23 descendants cleared2006: 6 descendants cleared2002: 2 descendants cleared2020: 25 descendants cleared2021: 14 descendants cleared2025: 32 descendants cleared2008: 6 descendants cleared2012: 26 descendants cleared2026: 18 descendants cleared2019: 25 descendants cleared2023: 23 descendants cleared2022: 29 descendants cleared1990200020102020
  1. This deviceK914838 Propaq 102,104,106,102EL,104EL,&106ELProtocol Systems, Inc. · 1992
  2. Descendant · cites it directly · 427 of its ownK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
  3. Descendant · 2 generations on · 426 of its ownK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
  4. Descendant · 3 generations on · 425 of its ownK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
  5. Descendant · 3 generations on · 272 of its ownK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
  6. Descendant · 4 generations on · 264 of its ownK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005

Showing 5 of 448 descendants. See all descendants

Descendants cleared per year

1998: 31999: 12002: 22003: 22004: 82005: 52006: 62007: 82008: 62009: 152010: 142011: 172012: 262013: 312014: 262015: 202016: 192017: 242018: 232019: 252020: 252021: 142022: 292023: 232024: 262025: 322026: 18
1998high 32 (2025) · low 0 (2000)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 448 · See all
  • K972020Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998 · cites it directly427descendants
  • K980879Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998 · 2 generations on426descendants
  • K9827769303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998 · 3 generations on425descendants
  • K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc. · 2004 · 3 generations on272descendants
  • K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc. · 2005 · 4 generations on264descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914838Propaq 102,104,106,102EL,104EL,&106ELProtocol Systems, Inc.1992—
+1K972020Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc.1998—
+2K980879Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc.1998—
+3K9827769303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc.1998—
+3K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…Cas Medical Systems, Inc.20041
+4K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL…Cas Medical Systems, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199830
199910
200220
200320
200480
200550
200660
200780
200860
2009150
2010140
2011170
2012260
2013311
2014262
2015200
2016190
2017240
2018230
2019250
2020250
2021140
2022290
2023230
2024260
2025320
2026180
FIG. 1 — Lineage of K914838, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

3 devices in this family have 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 MHX device

  1. #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (448)

See all 448

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972020Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc.1998427
K101264Tempus IC Professional Patient MonitorRemote Diagnostic Technologies, Ltd.201016
K990338Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor SystemPhysio-Control Corp.199912

Has anything in its family been recalled? (3 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.

  • K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
  • K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 11 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K972020 (Cas Medical Systems, Inc., 1998) has gone furthest, with 427 descendants of its own.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007: 152008: 162009: 132010: 202011: 122012: 162013: 212014: 132015: 142016: 132017: 142018: 112019: 72020: 112021: 52022: 152023: 82024: 52025: 82026 (partial year): 14
2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007: 96 days median2008: 58 days median2009: 57 days median2010: 90 days median2011: 81 days median2012: 88 days median2013: 120 days median2014: 248 days median2015: 203 days median2016: 149 days median2017: 134 days median2018: 203 days median2019: 243 days median2020: 196 days median2021: 195 days median2022: 189 days median2023: 229 days median2024: 181 days median2025: 192 days median2026 (partial year): 205 days median
2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007: 32008: 22009: 72010: 132011: 162012: 112013: 142014: 62015: 52016: 72017: 62018: 122019: 62022: 62023: 32024: 32025: 152026 (partial year): 21
2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007: 1312008: 2322009: 3822010: 9552011: 9492012: 6762013: 1,9972014: 1,6092015: 1,2842016: 1,1052017: 1,1152018: 2,1572019: 1,4622020: 1,7142021: 2,4232022: 1,4702023: 2,2542024: 2,8142025: 3,761
2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715963131
200816582232
200913577382
2010209013955
2011128116949
2012168811676
201321120141,997
20141324861,609
20151420351,284
20161314971,105
20171413461,115
201811203122,157
2019724361,462
20201119601,714
2021519502,423
20221518961,470
2023822932,254
2024518132,814
20258192153,761
20261420521—
Cite this page

510(k) Report. “K914838: Propaq 102,104,106,102EL,104EL,&106EL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914838

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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