510(k) Report

510(k) · Cleared

Cleared

Propaq 102, 104 and 106

K910772510(k) TraditionalCleared Apr 12, 199149-day reviewClass II21 CFR 870.1130

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

Protocol Systems, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Apr 12, 1991 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 436 devices in its family, counting itself, has a Class I recall. 435 later devices descend from it.

Decided
Apr 12, 1991
Review
49 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
0

435 later devices descend from it, 2 citing it directly. 1 of the 436 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1998: 3 descendants cleared2010: 13 descendants cleared2013: 30 descendants cleared2011: 16 descendants cleared2015: 20 descendants cleared2014: 25 descendants cleared, 1 with a Class I recall12017: 24 descendants cleared2004: 6 descendants cleared2007: 6 descendants cleared2005: 5 descendants cleared2016: 19 descendants cleared2018: 23 descendants cleared2006: 6 descendants cleared2003: 1 descendant cleared2002: 2 descendants cleared2009: 14 descendants cleared2020: 25 descendants cleared2021: 14 descendants cleared2008: 6 descendants cleared2012: 26 descendants cleared2026: 18 descendants cleared2019: 25 descendants cleared2024: 25 descendants cleared2025: 31 descendants cleared2023: 23 descendants cleared2022: 29 descendants cleared1990200020102020
  1. This deviceK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
  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 435 descendants. See all descendants

Descendants cleared per year

1998: 32002: 22003: 12004: 62005: 52006: 62007: 62008: 62009: 142010: 132011: 162012: 262013: 302014: 252015: 202016: 192017: 242018: 232019: 252020: 252021: 142022: 292023: 232024: 252025: 312026: 18
1998high 31 (2025) · low 0 (1999)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 435 · 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)K910772Propaq 102, 104 and 106Protocol Systems, Inc.1991—
+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
200220
200310
200460
200550
200660
200760
200860
2009140
2010130
2011160
2012260
2013300
2014251
2015200
2016190
2017240
2018230
2019250
2020250
2021140
2022290
2023230
2024250
2025310
2026180
FIG. 1 — Lineage of K910772, 1991–2026Source: 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.

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 DXN device

  1. #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (435)

See all 435

2 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

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.

  • 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 DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXN

28in 2025

2007: 272008: 232009: 462010: 432011: 342012: 362013: 342014: 292015: 302016: 302017: 332018: 222019: 332020: 242021: 232022: 252023: 352024: 172025: 282026 (partial year): 29
2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007: 118 days median2008: 82 days median2009: 73 days median2010: 94 days median2011: 72 days median2012: 116 days median2013: 150 days median2014: 133 days median2015: 97 days median2016: 144 days median2017: 184 days median2018: 235 days median2019: 156 days median2020: 198 days median2021: 190 days median2022: 137 days median2023: 182 days median2024: 107 days median2025: 142 days median2026 (partial year): 147 days median
2007high 235 (2018) · low 72 (2011)2026

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

Recalls per year · DXN

3in 2024

2008: 12009: 32011: 12013: 12016: 12019: 12024: 3
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DXN

239in 2025

2007: 212008: 82009: 172010: 142011: 102012: 192013: 722014: 472015: 622016: 542017: 902018: 6172019: 962020: 1302021: 1622022: 1552023: 1622024: 2702025: 239
2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, 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
200727118021
2008238218
20094673317
20104394014
20113472110
201236116019
201334150172
201429133047
20153097062
201630144154
201733184090
2018222350617
201933156196
2020241980130
2021231900162
2022251370155
2023351820162
2024171073270
2025281420239
2026291470—
Cite this page

510(k) Report. “K910772: Propaq 102, 104 and 106.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910772

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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