510(k) Report

510(k) · Cleared

Cleared

Oscillomate Blood Pressure Monitor-Model 9300

K925402510(k) TraditionalCleared Sep 17, 1993329-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

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

Cleared on Sep 17, 1993 after a 329-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 429 devices in its family, counting itself, has a Class I recall. 428 later devices descend from it.

Decided
Sep 17, 1993
Review
329 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
0

428 later devices descend from it, 2 citing it directly. 1 of the 429 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1998: 1 descendant cleared2004: 7 descendants cleared2007: 7 descendants cleared2006: 6 descendants cleared2003: 1 descendant cleared2002: 2 descendants cleared2013: 29 descendants cleared2010: 12 descendants cleared2009: 14 descendants cleared2017: 23 descendants cleared2005: 5 descendants cleared2020: 25 descendants cleared2011: 15 descendants cleared2015: 19 descendants cleared2008: 6 descendants cleared2016: 18 descendants cleared2012: 26 descendants cleared2018: 23 descendants cleared2021: 14 descendants cleared2014: 24 descendants cleared, 1 with a Class I recall12019: 25 descendants cleared2024: 25 descendants cleared2025: 31 descendants cleared2023: 23 descendants cleared2026: 18 descendants cleared2022: 29 descendants cleared1990200020102020
  1. This deviceK925402 Oscillomate Blood Pressure Monitor-Model 9300Cas Medical Systems, Inc. · 1993
  2. Descendant · cites it directly · 425 of its ownK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
  3. Descendant · 2 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
  4. Descendant · 3 generations on · 264 of its ownK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
  5. Descendant · 4 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
  6. Descendant · 5 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007

Showing 5 of 428 descendants. See all descendants

Descendants cleared per year

1998: 12002: 22003: 12004: 72005: 52006: 62007: 72008: 62009: 142010: 122011: 152012: 262013: 292014: 242015: 192016: 182017: 232018: 232019: 252020: 252021: 142022: 292023: 232024: 252025: 312026: 18
1998high 31 (2025) · low 0 (1999)2026

Class I recalls in this family

  • K123690 CAPNOSTREAM20P with Hifi C02 Monitoring10 generations on · 2014

Most influential descendants

Showing 5 of 428 · See all
  • K9827769303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998 · cites it directly425descendants
  • K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc. · 2004 · 2 generations on272descendants
  • K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc. · 2005 · 3 generations on264descendants
  • K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 4 generations on250descendants
  • K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 5 generations on197descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K925402Oscillomate Blood Pressure Monitor-Model 9300Cas Medical Systems, Inc.1993—
+1K9827769303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc.1998—
+2K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…Cas Medical Systems, Inc.20041
+3K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL…Cas Medical Systems, Inc.2005—
+4K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…Oridion Capnography, Inc.20063
+5K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200220
200310
200470
200550
200660
200770
200860
2009140
2010120
2011150
2012260
2013290
2014241
2015190
2016180
2017230
2018230
2019250
2020250
2021140
2022290
2023230
2024250
2025310
2026180
FIG. 1 — Lineage of K925402, 1993–2026Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (428)

See all 428

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

NumberDeviceApplicantDecidedDescendants
K9827769303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc.1998425
K032051Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649PAccess Battery, Inc.20041

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 · 10 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K982776 (Cas Medical Systems, Inc., 1998) has gone furthest, with 425 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—

More from Cas Medical Systems, Inc.

32 FDA decisions under this applicant name. See the company

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  • K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 20151 recall
  • K140430740 SelectCas Medical Systems, Inc. · 2014

Recent decisions in DXN

The DXN category page

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https://510kreport.com/device/K925402 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925402: Oscillomate Blood Pressure Monitor-Model 9300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925402

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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