510(k) · Cleared
ClearedNihon Khden Prefense Edns-9000 Series Central Nurse Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corp. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Dec 17, 2010 as substantially equivalent to K073550 (Nihon Kohden America, Inc., 2008) and 1 other predicate after a 143-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 17, 2010
- Review
- 143 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001433 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK001433 CNS-9300 Series Central StationNihon Kohden America, Inc. · 2000
- 2 generations backK023475 CNS-9700 Series Central Nurse Station and AccessoriesNihon Kohden America, Inc. · 2002 · Recalled
- 1 generation backK073550 Prefense Edns-9000 Series Nurse Central StationNihon Kohden America, Inc. · 2008
- This deviceK102106 Nihon Khden Prefense Edns-9000 Series Central Nurse StationNihon Kohden Corp. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001433 | CNS-9300 Series Central Station | Nihon Kohden America, Inc. | 2000 | — |
| −2 | K023475 | CNS-9700 Series Central Nurse Station and Accessories | Nihon Kohden America, Inc. | 2002 | 1 |
| −1 | K073550 | Prefense Edns-9000 Series Nurse Central Station | Nihon Kohden America, Inc. | 2008 | — |
| 0 (this device) | K102106 | Nihon Khden Prefense Edns-9000 Series Central Nurse Station | Nihon Kohden Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K073550 | Prefense Edns-9000 Series Nurse Central StationSummary page 1…RG. * The legally marketed equivalence: The predicate devices are the Nihon Kohden Prefense EDNS-9000 Series Central Nurse Station and Accessories per 510O(k) K073550 cleared on March 28, 2008 arid the Nihon Kohden ORG-9700A Multiple Patient Receiver per 5 10(k) K07 1058 cleared on J… | 2008 |
| * | K071058 | Multiple Patient Receiver, Model Org-9700ASummary page 1…00 Series Central Nurse Station and Accessories per 510O(k) K073550 cleared on March 28, 2008 arid the Nihon Kohden ORG-9700A Multiple Patient Receiver per 5 10(k) K07 1058 cleared on June 29, 2007 * A description of the device: The device is intended for use by medical professionals to pro… | 2007 |
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 10 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility.
The Pretense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receivers/transmitters and generates an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection is a function of the telemetry receivers/transmitters. Alarm determination can be configured to be performed by either the Prefense EONS-9000 Series Central Nurse Station or by the telemetry receivers/transmitters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102106: Nihon Khden Prefense Edns-9000 Series Central Nurse Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102106
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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