510(k) · Cleared
ClearedOscillomate Nibp / SP02 Ems Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cas Medical Systems, Inc. · DQA Oximeter
Cleared on Jul 16, 1998 as substantially equivalent to K972020 (Cas Medical Systems, Inc., 1998) and 1 other predicate after a 129-day review. Its family tree reaches back 2 generations to 1991. 1 of the 431 devices in its family, counting itself, has a Class I recall. 426 later devices descend from it.
- Decided
- Jul 16, 1998
- Review
- 129 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910772 (1991). 4 ancestors in all, the oldest K893221 (1990). 426 later devices descend from it, 2 citing it directly. 1 of the 431 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 1 generation backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- This deviceK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- Descendant · cites it directly · 425 of its ownK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- Descendant · cites it directly · 272 of its ownK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 264 of its ownK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- Descendant · 3 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
Showing 5 of 426 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K123690 CAPNOSTREAM20P with Hifi C02 Monitoring9 generations on · 2014
Most influential descendants
Showing 5 of 426 · 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 · cites it directly272descendants
- K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc. · 2005 · 2 generations on264descendants
- K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 3 generations on250descendants
- K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 4 generations on197descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −1 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| +1 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| +1 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| +2 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| +3 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| +4 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 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.
Top candidate predicates for a new DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor Cleared while this submission was under review Summary page 2…stantial equivalence to the following legally marketed device: Aspect vice mmber Monitor Propaq 100 SERIES Multi-parameter Patient Monitor NIBP Oscillomate 9001D NIBP | K972020 * by CAS Medical Systems Oximetry Model 8500 by Nonin K893221 Medical, Inc. * As of the date of this submission this device was… | 1998 |
| * | K893221 | Model 8500 Hand Held Pulse OximeterSummary page 2…Aspect vice mmber Monitor Propaq 100 SERIES Multi-parameter Patient Monitor NIBP Oscillomate 9001D NIBP | K972020 * by CAS Medical Systems Oximetry Model 8500 by Nonin K893221 Medical, Inc. * As of the date of this submission this device was pending 510k approval. Device Description The 9002D Oscillom… | 1990 |
What descends from it? (426)
See all 4262 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 9 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K982776 (Cas Medical Systems, Inc., 1998) has gone furthest, with 425 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The Oscillomate 9002 NIBP / Sp02 Monitor Non-invasively measures blood pressure, oxygen saturation and the pulse of the adult and pediatric patient in EMS environments by health care professionals. It is not designed for continuous unsupervised monitoring.
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/K980879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980879: Oscillomate Nibp / SP02 Ems Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980879
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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