510(k) Report

510(k) · Cleared

Cleared

Datex-Ohmeda S/5 Network and Central '01

K013246510(k) TraditionalCleared Dec 11, 200174-day reviewClass II21 CFR 870.2300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Datex-Ohmeda · MSX System, Network And Communication, Physiological Monitors

Cleared on Dec 11, 2001 as substantially equivalent to K000647 (Datex-Ohmeda, Inc., 2000) after a 74-day review. Its family tree reaches back 1 generation to 2000. 10 later devices descend from it.

Decided
Dec 11, 2001
Review
74 days
Class
Class II
Product code
MSX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000647 (2000). 10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2015: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2005: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2012: 1 descendant cleared2011: 1 descendant cleared2009: 1 descendant clearedK000647 · Datex-Ohmeda Network and Central · Datex-Ohmeda, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 4 descendants K000647 · Datex-Ohmeda Network and Central · Datex-Ohmeda, Inc. · 20000+5
  1. Root · 1 generation backK000647 Datex-Ohmeda Network and CentralDatex-Ohmeda, Inc. · 2000
  2. This deviceK013246 Datex-Ohmeda S/5 Network and Central '01Datex-Ohmeda · 2001
  3. Descendant · cites it directly · 9 of its ownK022507 Datex-Ohmeda S/5 Network and Central '02Datex-Ohmeda · 2002
  4. Descendant · 2 generations on · 7 of its ownK033281 Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03…Datex-Ohmeda · 2003
  5. Descendant · 3 generations on · 6 of its ownK042771 GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3Datex-Ohmeda · 2004
  6. Descendant · 4 generations on · 5 of its ownK052972 Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3GE Healthcare · 2005 · Recalled
  7. Descendant · 5 generations on · 4 of its ownK071097 Navigator Applications SuiteGE Healthcare Finland Oy · 2007

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 12005: 12007: 12008: 12009: 12011: 12012: 12015: 1
2002high 1 (2002) · low 0 (2006)2026

Most influential descendants

Showing 5 of 10 · See all
  • K022507Datex-Ohmeda S/5 Network and Central '02Datex-Ohmeda · 2002 · cites it directly9descendants
  • K033281Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03 SoftwareDatex-Ohmeda · 2003 · 2 generations on7descendants
  • K042771GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3Datex-Ohmeda · 2004 · 3 generations on6descendants
  • K052972Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3GE Healthcare · 2005 · 4 generations on5descendants
  • K071097Navigator Applications SuiteGE Healthcare Finland Oy · 2007 · 5 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000647Datex-Ohmeda Network and CentralDatex-Ohmeda, Inc.2000—
0 (this device)K013246Datex-Ohmeda S/5 Network and Central '01Datex-Ohmeda2001—
+1K022507Datex-Ohmeda S/5 Network and Central '02Datex-Ohmeda2002—
+2K033281Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03 SoftwareDatex-Ohmeda2003—
+3K042771GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3Datex-Ohmeda2004—
+4K052972Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3GE Healthcare20053
+5K071097Navigator Applications SuiteGE Healthcare Finland Oy2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200410
200510
200710
200810
200910
201110
201210
201510
FIG. 1 — Lineage of K013246, 2000–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242750 Central Stationscore 21.5 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K000647Datex-Ohmeda Network and Central
Summary page 1
…1 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda S/5 Network and Central and Information Center (510(k) number: K000647). et 324k Page 2 of 5 DEVICE DESCRIPTION as required by 807.92(a¥4) The Datex-Ohmeda S/5 Network (also referre…
Datex-Ohmeda, Inc.2000—

Also cleared against K000647: 1 other device →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022507Datex-Ohmeda S/5 Network and Central '02Datex-Ohmeda20029

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?

  • Its one ancestor has no recall.
  • Of its descendants, K022507 (Datex-Ohmeda, 2002) has gone furthest, with 9 descendants of its own.
  • 1 other device also cites its predicate K000647.

How does its category compare?

All MSX devices

MSX 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

2007: 42008: 12009: 12010: 32011: 72012: 42013: 22014: 32015: 52016: 32017: 22018: 42019: 42020: 52021: 32022: 52023: 32024: 42025: 42026 (partial year): 5
2007high 7 (2011) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSX

295in 2025

2007: 58 days median2010: 43 days median2011: 72 days median2012: 145 days median2014: 165 days median2015: 138 days median2016: 174 days median2018: 111 days median2019: 92 days median2020: 193 days median2021: 227 days median2022: 177 days median2023: 244 days median2024: 212 days median2025: 295 days median2026 (partial year): 145 days median
2007high 295 (2025) · low 43 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MSX

1in 2025

2007: 12008: 12009: 22010: 12011: 12012: 22015: 22017: 22018: 12022: 12025: 12026 (partial year): 2
2007high 2 (2009) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MSX

19in 2025

2007: 52008: 62009: 72010: 142011: 32012: 42013: 172014: 322015: 312016: 112017: 162018: 152019: 152020: 252021: 172022: 182023: 102024: 322025: 19
2007high 32 (2014) · low 3 (2011)2025

MAUDE reports naming product code MSX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200745815
20081—16
20091—27
2010343114
201177213
2012414524
20132—017
20143165032
20155138231
20163174011
20172—216
20184111115
2019492015
20205193025
20213227017
20225177118
20233244010
20244212032
20254295119
202651452—

What is it indicated for?

The Datex-Ohmeda S/5™ Network and Central transfers information between networked Datex-Ohmeda devices in the Datex-Ohmeda monitor network. It also allows information transfer between several Centrals. Within one Datex-Ohmeda monitor network it allows a networked device to display, store, print and otherwise process information received from other networked devices. The Datex-Ohmeda S/5™ Central maintains the network connections between the Datex-Ohmeda…

Read the full statement (176 words)

The Datex-Ohmeda S/5™ Network and Central transfers information

between networked Datex-Ohmeda devices in the Datex-Ohmeda monitor

network. It also allows information transfer between several Centrals.

Within one Datex-Ohmeda monitor network it allows a networked device

to display, store, print and otherwise process information received from

other networked devices.

The Datex-Ohmeda S/5™ Central maintains the network connections

between the Datex-Ohmeda bedside monitors and other networked devices

in Datex-Ohmeda monitor network. Furthermore, it coordinates the

transfer of information between devices in the Datex-Ohmeda S/5™

Network as well as between the Datex-Ohmeda Network and Hospital

Information Systems (HIS).

The Datex-Ohmeda S/5™ Central can be used for remote monitor

management, storing, printing, viewing or otherwise processing of

information from several bedside monitors or other networked devices.

The Datex-Ohmeda S/5™ ViewStation can be used for remote monitor

management, printing, viewing or otherwise processing of information

from several bedside monitors or other networked devices.

The Datex-Ohmeda S/5™ Network will be used for patients in the hospital

and it is meant for continuous use.

The device is for use by qualified personnel only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K000647

1 other device cites the same predicate.

  • K013387Datex-Ohmeda S/5 Web ViewerDatex-Ohmeda · 2002

More from Datex-Ohmeda

40 FDA decisions under this applicant name. See the company

  • K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda · 20132 recalls
  • K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 20121 Class I recall
  • K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 20113 Class I recalls
  • K071142GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007
  • K042891Datex-Ohmeda Oxy-Afr SensorDatex-Ohmeda · 2005

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https://510kreport.com/device/K013246 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013246: Datex-Ohmeda S/5 Network and Central '01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013246

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026