510(k) · Cleared
ClearedOscillomate Non-Invasive Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cas Medical Systems, Inc. · DXW System, Phonocatheter, Intracavitary
Cleared on May 5, 1998 as substantially equivalent to K910772 (Protocol Systems, Inc., 1991) and 1 other predicate after a 337-day review. Its family tree reaches back 1 generation to 1991. 1 of the 430 devices in its family, counting itself, has a Class I recall. 427 later devices descend from it.
- Decided
- May 5, 1998
- Review
- 337 days
- Class
- Class II
- Product code
- DXW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910772 (1991). 2 ancestors in all. 427 later devices descend from it, 1 citing it directly. 1 of the 430 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- This deviceK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- Descendant · cites it directly · 426 of its ownK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- Descendant · 2 generations on · 425 of its ownK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 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
- Descendant · 3 generations on · 264 of its ownK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- Descendant · 4 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
Showing 5 of 427 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K123690 CAPNOSTREAM20P with Hifi C02 Monitoring10 generations on · 2014
Most influential descendants
Showing 5 of 427 · See all- K980879Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998 · cites it directly426descendants
- K9827769303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998 · 2 generations on425descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| 0 (this device) | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| +1 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| +2 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| +2 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| +3 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| +4 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 14 | 0 |
| 2010 | 12 | 0 |
| 2011 | 15 | 0 |
| 2012 | 26 | 0 |
| 2013 | 29 | 0 |
| 2014 | 24 | 1 |
| 2015 | 19 | 0 |
| 2016 | 18 | 0 |
| 2017 | 23 | 0 |
| 2018 | 23 | 0 |
| 2019 | 25 | 0 |
| 2020 | 25 | 0 |
| 2021 | 14 | 0 |
| 2022 | 29 | 0 |
| 2023 | 23 | 0 |
| 2024 | 25 | 0 |
| 2025 | 31 | 0 |
| 2026 | 18 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K910772 | Propaq 102, 104 and 106Summary page 5…stantial Equivalence and K Number Non-Invasive Blood Pressure(NIBP) using oscillometric method Protocol Systems, Inc. PROPAQ 100 Series Ultra-Portable Patient Monitor K910772 NIBP Module referenced in K914838 January 10, 1992 Feature CAS OSCILLOMATE 9001D Protocol Propaq 100 series Difference and Ju… | 1991 |
| * | K914838 | Propaq 102,104,106,102EL,104EL,&106ELSummary page 5…Non-Invasive Blood Pressure(NIBP) using oscillometric method Protocol Systems, Inc. PROPAQ 100 Series Ultra-Portable Patient Monitor K910772 NIBP Module referenced in K914838 January 10, 1992 Feature CAS OSCILLOMATE 9001D Protocol Propaq 100 series Difference and Justification 1. Intended Use Physi… | 1992 |
What descends from it? (427)
See all 4271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980879 | Oscillomate Nibp / SP02 Ems Monitor | 1998 | 426 |
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?
How does its category compare?
All DXW devicesDXW System, Phonocatheter, Intracavitary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXW
FDA has decided no DXW device since 2007.
Median 510(k) review, days · DXW
Too few DXW 510(k)s in any year since 2007 to give a median.
Recalls per year · DXW
No recall names DXW since 2007.
Adverse event reports per year · DXW
No MAUDE report names DXW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Oscillomate 9001D monitor non-invasively measures the blood pressure of adult and pediatric patients primarily in the emergency care environment. The monitor automatically inflates an occluding cuff and, using the Oscillometric measurement technique, determines systolic, diastolic and pulse rate.
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/K972020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972020: Oscillomate Non-Invasive Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972020
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026