510(k) · Cleared
ClearedPrefense Edns-9000 Series Nurse Central Station
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 Mar 28, 2008 as substantially equivalent to K023475 (Nihon Kohden America, Inc., 2002) after a 101-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Mar 28, 2008
- Review
- 101 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001433 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001433 CNS-9300 Series Central StationNihon Kohden America, Inc. · 2000
- 1 generation backK023475 CNS-9700 Series Central Nurse Station and AccessoriesNihon Kohden America, Inc. · 2002 · Recalled
- This deviceK073550 Prefense Edns-9000 Series Nurse Central StationNihon Kohden America, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK102106 Nihon Khden Prefense Edns-9000 Series Central Nurse StationNihon Kohden Corp. · 2010
Most influential descendants
Showing 1 of 1 · See all- K102106Nihon Khden Prefense Edns-9000 Series Central Nurse StationNihon Kohden Corp. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001433 | CNS-9300 Series Central Station | Nihon Kohden America, Inc. | 2000 | — |
| −1 | K023475 | CNS-9700 Series Central Nurse Station and Accessories | Nihon Kohden America, Inc. | 2002 | 1 |
| 0 (this device) | K073550 | Prefense Edns-9000 Series Nurse Central Station | Nihon Kohden America, Inc. | 2008 | — |
| +1 | K102106 | Nihon Khden Prefense Edns-9000 Series Central Nurse Station | Nihon Kohden Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K023475 | CNS-9700 Series Central Nurse Station and AccessoriesSummary page 1…iver per DRG. * The legally marketed equivalence: The predicate-marketed device is the CNS-9700 Series Central Nurse station and accessories per 5 10(k) K(023475, commercial distribution dated October 16, 2002. • A description of the device: The device is intended for use by… | 2002 |
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 |
|---|---|---|---|
| K102106 | Nihon Khden Prefense Edns-9000 Series Central Nurse Station | 2010 | 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 8 years and passes through 1 company; a new generation was cleared every 5.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K102106 (Nihon Kohden Corp., 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023475.
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?
The Prefense EDNS-9000 Series Central Nurse Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from telemetry receivers/transmitters and alarms when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the telemetry unit.
This product will be available for use by medical personnel on all patient populations with a medical facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073550: Prefense Edns-9000 Series Nurse Central Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073550
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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