510(k) · Cleared
ClearedFukuda Denshi Dynascope Model DS-7000/7000M 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 Aug 29, 2008 as substantially equivalent to K964187 (Fukuda Denshi USA, Inc., 1997) and 4 other predicates after a 58-day review. Its family tree reaches back 6 generations to 1997. 3 later devices descend from it.
- Decided
- Aug 29, 2008
- Review
- 58 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K962603 (1997). 24 ancestors in all, the oldest K894628 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 1 generation backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- This deviceK081891 Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK083697 Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK150030 Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK134046 Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc. · 2015 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc. · 2009 · cites it directly2descendants
- K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015 · 2 generations on0descendants
- K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −1 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| 0 (this device) | K081891 | Fukuda Denshi Dynascope Model DS-7000/7000M Patient Monitor | Fukuda Denshi USA, Inc. | 2008 | — |
| +1 | K083697 | Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model… | Fukuda Denshi USA, Inc. | 2009 | — |
| +2 | K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | 2015 | — |
| +2 | K134046 | Fukuda Denshi Dynascope Model DS-8100N/8100M Patient Monitor | Fukuda Denshi USA, Inc. | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 2 | 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.
Planning a device in MHX? 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? (5)
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 2…del DS-7000/7000M Patient Monitor Legally Marketed Device: Fukuda Denshi DynaScope Model DS-5300 Patient Monitor 510(k) # K964187 Fukuda Denshi DynaScope Model DS-7141 Portable Patient Monitor 5 10(k) # K040246… | 1997 |
| * | K040246 | Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorSummary page 2…Denshi DynaScope Model DS-5300 Patient Monitor 510(k) # K964187 Fukuda Denshi DynaScope Model DS-7141 Portable Patient Monitor 5 10(k) # K040246 In addition, several functions of the DS-7000/7000M Patient Monitor utilize technology incorporate… | 2004 |
| * | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterSummary page 2…stem used in the DS-7000 is the same as that used in the Nellcor Puritan Bennett model "OxiMax N-560 Pulse Oximeter" cleared under 510(k) # K021090. The SpO2 measurement system used in the DS-7000M is the same as that used in the Masimo Corporati… | 2002 |
| * | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model…Summary page 2…tem used in the DS-7000M is the same as that used in the Masimo Corporation model "Masimo SET RAD 5 Pulse Oximeter" cleared under 5 10(k) # K033296. The multigas measurement system used in the DS-7000/7000M is the same as that used in the Critica… | 2004 |
| * | K012059 | 8100/8500 Vital Signs MonitorSummary page 2…used in the DS-7000/7000M is the same as that used in the Criticare Systems, Inc. model "8500 Vital Signs Monitor" cleared under 5 10(k) # K012059. DS-7000/7000M 5 10(k) 5 10(k) Summary 6/13/2008… | 2001 |
| † | K970585 | Fukuda Denshi Dynascope Model DS-5800 Central Station Monitor | 1997 |
| † | K000746 | Fukuda Denshi Dynascope, Model DS-5800NX | 2000 |
| † | K020084 | Fukuda Denshi Dynascope Model DS-5700 | 2002 |
| † | K980728 | Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083697 | Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model… | 2009 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K083697 (Fukuda Denshi USA, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 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. 2008, 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?
Use of the Fukuda Denshi DynaScope Model DS-7000/7000M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NJBP), pulse rate, arterial oxygen saturation (SpO 2 ), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide…
Read the full statement (200 words)
Use of the Fukuda Denshi DynaScope Model DS-7000/7000M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NJBP), pulse rate, arterial oxygen saturation (SpO 2 ), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO 2), nitrous oxide concentration (N 2 0), oxygen concentration (02), and anesthetic agent concentration (AG). The target populations of the system are adult, pediatric, and neonatal patients with the exception of the ST segment and arrhythmia analysis, for which the target populations are adult and pediatric only. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-7000/7000M is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7000/7000M also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081891: Fukuda Denshi Dynascope Model DS-7000/7000M 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/K081891
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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