510(k) · Cleared
ClearedFukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fukuda Denshi USA, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Mar 16, 2015 as substantially equivalent to K964187 (Fukuda Denshi USA, Inc., 1997) and 8 other predicates after a 67-day review. Its family tree reaches back 13 generations to 1997. 1 of the 151 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 16, 2015
- Review
- 67 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 13 generations to K962603 (1997). 150 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet. 1 of the 151 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations between
- 3 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 2 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 1 generation backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- This deviceK150030 Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015
Show all 13 generations
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 11 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 10 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 9 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 8 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 7 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 6 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 5 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 4 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 3 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 2 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 1 generation backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- This deviceK150030 Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015
Class I recalls in this family
- K970209 Capnocheck Plus7 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −12 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −11 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −10 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −9 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −8 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −7 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −6 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −5 | 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 | — |
| −3 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −2 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −1 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| 0 (this device) | K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 5 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 7 | 0 |
| 1995 | 12 | 0 |
| 1996 | 8 | 0 |
| 1997 | 12 | 1 |
| 1998 | 11 | 0 |
| 1999 | 13 | 0 |
| 2000 | 14 | 0 |
| 2001 | 4 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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 |
|---|---|---|---|
| * | K964187 | Fukada Denshi Dynascope Model DS-5300 Patient MonitorSummary page 5…Product Regulation 510(k) K# Classification Name Panel Code Number K964187 DSI 870.1025 Arrhythmia detector and Cardiovascular alarm… | 1997 |
| * | K083697 | Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Summary page 5…alarm (including ST- segment measurement and alarm). K083697 BZQ 868.2375 Breathing frequency Anesthesiology monit… | 2009 |
| * | K062754 | Gas Module SE, Model 0998-00-0481-02Summary page 5…FLL 880.2910 Clinical electronic General thermometer. Hospital K062754 BZK 868.1850 Monitoring spirometer Anesthesiology CBS 868.1620 Halot… | 2006 |
| * | K981066 | Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel ElectrocardiographSummary page 5…BZK 868.1850 Monitoring spirometer Anesthesiology CBS 868.1620 Halothane gas analyzer Anesthesiology K981066 DPS 870.2340 Electrocardiograph Cardiovascular K021090 DQA 870.2700 Oxime… | 1998 |
| * | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterSummary page 5…CBS 868.1620 Halothane gas analyzer Anesthesiology K981066 DPS 870.2340 Electrocardiograph Cardiovascular K021090 DQA 870.2700 Oximeter Anesthesiology K100428 DQA 870.2700 Oxime… | 2002 |
| * | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-OximeterSummary page 5…DPS 870.2340 Electrocardiograph Cardiovascular K021090 DQA 870.2700 Oximeter Anesthesiology K100428 DQA 870.2700 Oximeter Anesthesiology K094012 CCK 868.1400 Carbo… | 2010 |
| * | K094012 | CAPNOSTREAM20 with MICROMEDICO2 ModuleSummary page 5…DQA 870.2700 Oximeter Anesthesiology K100428 DQA 870.2700 Oximeter Anesthesiology K094012 CCK 868.1400 Carbon Dioxide Gas Anesthesiology Analy… | 2010 |
| * | K042601 | Capnostat 5Summary page 5…thesiology K094012 CCK 868.1400 Carbon Dioxide Gas Anesthesiology Analyzer K042601 CCK 868.1400 Carbon Dioxide Gas Anesthesiology Analy… | 2004 |
| * | K053234 | PM-9000 Express Patient MonitorSummary page 5…Analyzer K042601 CCK 868.1400 Carbon Dioxide Gas Anesthesiology Analyzer K053234 MWI 870.2300 Cardiac Monitor Cardiovascular (incl… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 24 of the 150 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K964187.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor provides a simple and reliable method to display and document the continuous hemodynamic, cardiovascular observations that are typically required of critically ill patients. The target populations of the system are adult, pediatric, and neonatal patients, who may be located in a hospitals ICU, CCU, OR, ER, recovery or other critical care area, with the exception of the ST segment…
Read the full statement (237 words)
The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor provides a simple and reliable method to display and document the continuous hemodynamic, cardiovascular observations that are typically required of critically ill patients. The target populations of the system are adult, pediatric, and neonatal patients, who may be located in a hospitals ICU, CCU, OR, ER, recovery or other critical care area, with the exception of the ST segment, arrhythmia analysis, and SpHb for which the target populations are adult and pediatric only excluding neonates. The DS-8000 Series monitor can also be used to follow patients whose treatment requires close observation of specific physiological parameters. These patients may be in a clinic or other healthcare environment under the care of a physician.
The availability of DS-LAN connection, through either a built in Ethernet LAN or external telemetry transmitter, allows remote monitoring when combined with Fukuda Denshi Central Station Monitors.
Parameters such as ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO3), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb), plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (COy), nitrous oxide concentration (N20), oxygen concentration (O;), anesthetic agent concentration (AG), and Spirometry may be monitored individually or in any grouping required by the clinician.
The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor is not recommended for home use, when it has not been ordered by a physician.
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/K150030 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150030: Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150030
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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