510(k) · Cleared
ClearedFukuda Denshi
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 11, 2011 as substantially equivalent to K033711 (Fukuda Denshi USA, Inc., 2004) after a 137-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Mar 11, 2011
- Review
- 137 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K897063 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK897063 Fukuda Denshi Model DS-3300 EtrFukuda Denshi USA, Inc. · 1990
- 2 generations backK980728 Fukuda Denshi Dynascope Model DS-5000 Series Telemetry SystemFukuda Denshi USA, Inc. · 1998
- 1 generation backK033711 Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemFukuda Denshi USA, Inc. · 2004
- This deviceK103134 Fukuda DenshiFukuda Denshi USA, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K897063 | Fukuda Denshi Model DS-3300 Etr | Fukuda Denshi USA, Inc. | 1990 | — |
| −2 | K980728 | Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System | Fukuda Denshi USA, Inc. | 1998 | — |
| −1 | K033711 | Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System | Fukuda Denshi USA, Inc. | 2004 | — |
| 0 (this device) | K103134 | Fukuda Denshi | Fukuda Denshi USA, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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.
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? (1)
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 |
|---|---|---|---|
| * | K033711 | Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemSummary page 2…REVISED 510(k) Summary 1-30-2011 Fukuda Denshi Model LX-7230KM/7230N Transmitter Legally Marketed Device: Fukuda Denshi model LX-5630 Transmitter, #K033711 In addition, the SP0 2 measurement function of the LX-7230KM/7230N Transmitter utilizes technology incorporated into previ… | 2004 |
| † | K053419 | Konica Minolta Pulsox-300, 300I | 2006 |
| † | K060576 | Nellcor Oximax N-600X Pulse Oximeter | 2006 |
| † | 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?
No later submission names this one as a predicate yet.
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 21 years and passes through 1 company; a new generation was cleared every 6.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
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. 2011, 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 DS-7000 Series Telemetry Monitoring System is intended to be used as central station monitoring system for the evaluation of the cardiovascular system. It is intended to be used by or on the order of a physician or similarly qualified healthcare professional. The DS-7000 Series Telemetry Monitoring System is intended to be used in hospital environments: ER, ICU, a clinic or similar settings. The DS-7000 Series Telemetry Monitoring System is intended…
Read the full statement (111 words)
The DS-7000 Series Telemetry Monitoring System is intended to be used as central station monitoring system for the evaluation of the cardiovascular system. It is intended to be used by or on the order of a physician or similarly qualified healthcare professional. The DS-7000 Series Telemetry Monitoring System is intended to be used in hospital environments: ER, ICU, a clinic or similar settings. The DS-7000 Series Telemetry Monitoring System is intended to be used in those situations where the patient is being monitored by a Fukuda Denshi DS-5000-7000 Series bedside monitor, or patient worn telemetry transmitter where remote, central station monitoring is desired. This system is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103134: Fukuda Denshi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103134
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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