510(k) · Cleared
ClearedWireless Lan (Local Area Network) - Wireless Ethernet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Electronics, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Oct 22, 1997 as substantially equivalent to K964750 (Marquette Electronics, Inc., 1997) after a 168-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Oct 22, 1997
- Review
- 168 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921669 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 1 generation backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- This deviceK971683 Wireless Lan (Local Area Network) - Wireless EthernetMarquette Electronics, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −1 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| 0 (this device) | K971683 | Wireless Lan (Local Area Network) - Wireless Ethernet | Marquette Electronics, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K964750 | Eagle 4000 Patient MonitorSummary page 1…the Eagle 4000 using wired LAN to the Eagle 4000 using wireless LAN. Its 510(k) equivalency references include the following: K?12799 Eagle System K920790 Eagle Monitor K964750 Eagle 4000 Patient Monitor 4, Device Description The Marquette Eagle 4000 Patient Monitor is a multi-parameter p… | 1997 |
| † | K812799 | DCATS | 1981 |
| † | K920790 | Marquette Eagle Monitor | 1994 |
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 4 years and passes through 1 company; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K964750.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The Marquette Eagle 4000 Patient Monitor is a multi-parameter patient monitoring system that is cleared to market as part of Marquette’s wired Unity network. The Marquette Eagle 4000 Patient Monitor is now indicated for use on Marquette’s wireless LAN. Wireless LAN is a method of communicating to the Marquette Unity Network using a wireless connection. This capability: ~provides identical networking function to standard Ethemnet; ~permits integration to…
Read the full statement (162 words)
The Marquette Eagle 4000 Patient Monitor is a multi-parameter patient monitoring system that is cleared to market as part of Marquette’s wired Unity network. The Marquette Eagle 4000 Patient Monitor is now indicated for use on Marquette’s wireless LAN.
Wireless LAN is a method of communicating to the Marquette Unity Network using a wireless connection. This capability:
~provides identical networking function to standard Ethemnet;
~permits integration to the network without physical connection to the Ethernet wall plate.
This device is viewed as a technology change and can be used with various other Marquette devices. Marquette has clearances for various patient monitors and its central station which are part of its wired Unity network. The intended patient population is limited to the same population as the device that the technology is being used with.
This device should be used by people who are trained in the use of the equipment.
This device is intended to be used within the hospital / facility environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971683 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971683: Wireless Lan (Local Area Network) - Wireless Ethernet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971683
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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