510(k) · Cleared
ClearedCentral Telemetry System, Model Wep-4200A Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 1, 2004 as substantially equivalent to K945944 (Nihon Kohden America, Inc., 1995) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 1, 2004
- Review
- 105 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945944 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK945944 Nihon Kohden Wep-8430A Central Telemetry SystemNihon Kohden America, Inc. · 1995
- This deviceK040395 Central Telemetry System, Model Wep-4200A SeriesNihon Kohden America, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945944 | Nihon Kohden Wep-8430A Central Telemetry System | Nihon Kohden America, Inc. | 1995 | — |
| 0 (this device) | K040395 | Central Telemetry System, Model Wep-4200A Series | Nihon Kohden America, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K945944 | Nihon Kohden Wep-8430A Central Telemetry SystemSummary page 1…rms per 21 CFR Part 870.1025, * The legally marketed equivalence: The predicate device is Nihon Kohden's Central Telemetry system, WEP-8430A, 510K: K945944, dated 11/27/95. All features available with the new WEP-4200 are also available on Nihon Kohden BSM-4104A, 510K: K001693… | 1995 |
| * | K001693 | Life Scope P, Model BSM-4100 SeriesSummary page 1…Telemetry system, WEP-8430A, 510K: K945944, dated 11/27/95. All features available with the new WEP-4200 are also available on Nihon Kohden BSM-4104A, 510K: K001693 * A description of the device: The system provides for monitoring ECG, ST levels, VPC rate, arrhythmia events, SpO2… | 2000 |
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?
- None of the 2 ancestors has a recall.
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 device is comprised of transmitters and a receiver communicated via WMTS radio frequency. The series of device are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The…
Read the full statement (177 words)
The device is comprised of transmitters and a receiver communicated via WMTS radio frequency. The series of device are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor patients' physiological data including heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP), body temperature respiratory rate and apnea. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device receives physiological signals via radio frequency from the transmitters. The device has the capability of communicating with external devices, such as personal computers. Vital sign data can be sent to a central monitor through the network via network card.
The device will be available for use by medical personnel on patients within a medical facility including adults, children and infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040395: Central Telemetry System, Model Wep-4200A Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040395
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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