510(k) · Cleared
ClearedFukuda Denshi Dynascope Model DS-5000 Central Telemetry System
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 Jun 3, 2004 as substantially equivalent to K980728 (Fukuda Denshi USA, Inc., 1998) and 1 other predicate after a 190-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Jun 3, 2004
- Review
- 190 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K897063 (1990). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK897063 Fukuda Denshi Model DS-3300 EtrFukuda Denshi USA, Inc. · 1990
- 1 generation backK980728 Fukuda Denshi Dynascope Model DS-5000 Series Telemetry SystemFukuda Denshi USA, Inc. · 1998
- This deviceK033711 Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemFukuda Denshi USA, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK103134 Fukuda DenshiFukuda Denshi USA, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103134Fukuda DenshiFukuda Denshi USA, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K897063 | Fukuda Denshi Model DS-3300 Etr | Fukuda Denshi USA, Inc. | 1990 | — |
| −1 | K980728 | Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System | Fukuda Denshi USA, Inc. | 1998 | — |
| 0 (this device) | K033711 | Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System | Fukuda Denshi USA, Inc. | 2004 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (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 |
|---|---|---|---|
| * | K980728 | Fukuda Denshi Dynascope Model DS-5000 Series Telemetry SystemSummary page 1…(§870.1025) Class III Legally Marketed Device: Fukuda Denshi DS-5000 Telemetry Monitoring System (K 980728) Minolta PULSOX-3Li Oximeter (K010413) DS-5000 Telemetry 1… | 1998 |
| * | K010413 | Minolta Pulsox-3SI, Pulsox-3IA, Pulsox-3LISummary page 1…Device: Fukuda Denshi DS-5000 Telemetry Monitoring System (K 980728) Minolta PULSOX-3Li Oximeter (K010413) DS-5000 Telemetry 1 5/3/2004 Special 5 10(k)… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103134 | Fukuda Denshi | 2011 | 0 |
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 14 years and passes through 1 company; a new generation was cleared every 8.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K103134 (Fukuda Denshi USA, Inc., 2011) has gone furthest, with 0 descendants of its own.
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.
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 DS-5000 series Telemetry Monitoring System is indicated in those situations where centrally located hom cJynamic monitoring (central station monitoring) of one or more patients cardioviz,cular condition is desired and those patients are currently monitored by a Fukuda Denshi bedside monitor, or is wearing a Fukuda Denshi telemetry transmitter. Use of this device is indicated only in a medically supervised healthcare environment (e.g. ER, ICU or clinic). It is not intended for home use. This device is intended for Prescription Use Only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033711 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033711: Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033711
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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