510(k) Report

510(k) · Cleared

Cleared

Centurion Central Station Arrhythmia Patient Monitoring System

K980045510(k) TraditionalCleared Nov 16, 1998314-day reviewClass II21 CFR 870.1025

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

Invivo Research, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on Nov 16, 1998 as substantially equivalent to K962473 (Data Critical Corporation, 1997) and 3 other predicates after a 314-day review. Its family tree reaches back 2 generations to 1990.

Decided
Nov 16, 1998
Review
314 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K903702 (1990). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor1995: 1 other ancestor1991: 1 other ancestorK903702 · Model 90421 Flexport Interface · Spacelabs, Inc. · 1990 · recalledK962473 · (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with · Data Critical Corporation · 1997199019921994199619982000
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors K962473 · (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with · Data Critical Corporation · 1997K903702 · Model 90421 Flexport Interface · Spacelabs, Inc. · 1990 · recalled0
  1. Root · 2 generations backK903702 Model 90421 Flexport InterfaceSpacelabs, Inc. · 1990 · Recalled
  2. 1 generation backK962473 (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory…Data Critical Corporation · 1997
  3. This deviceK980045 Centurion Central Station Arrhythmia Patient Monitoring SystemInvivo Research, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K903702Model 90421 Flexport InterfaceSpacelabs, Inc.19901
−1K962473(Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory…Data Critical Corporation1997—
0 (this device)K980045Centurion Central Station Arrhythmia Patient Monitoring SystemInvivo Research, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
199310
199410
199510
FIG. 1 — Lineage of K980045, 1990–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 DSI? 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 DSI device

  1. #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (4)

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
*K962473(Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and…
Summary page 1
…cation: Class III (see 21 CFR - 870.1025). Predicate Devices: The predicate device(s) are the PCI/Vitalcom Inc. Central Station with Arrhythmia Monitor (510(k) numbers K962473 and K925411), the Datascope VISA Central Station with Arrhythmia Monitor(510(k) number K913676), and the Critikon Central Station…
Data Critical Corporation1997—
*K925411Model 2041-PC/ST Cardiac Telemetry Monitor
Summary page 1
…s III (see 21 CFR - 870.1025). Predicate Devices: The predicate device(s) are the PCI/Vitalcom Inc. Central Station with Arrhythmia Monitor (510(k) numbers K962473 and K925411), the Datascope VISA Central Station with Arrhythmia Monitor(510(k) number K913676), and the Critikon Central Station with Arrhyt…
Accucore, Inc.1993—
*K913576Datascope Model Visa Central Monitor
Our OCR of the scanned summary read K913676, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Datascope VISA Central Station with Arrhythmia Monitor”.
Accucore, Inc.1992—
*K933404Critikon Central Statin Monitor
Summary page 1
…and K925411), the Datascope VISA Central Station with Arrhythmia Monitor(510(k) number K913676), and the Critikon Central Station with Arrhythmia Monitor (510(k) number K933404). These predicate devices have the same performance specifications as the Centurion™ Central Station with Arrhythmia Patient Moni…
Critikon Company, LLC1994—

Also cleared against K962473: 1 other device →

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 8 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • 1 other device also cites its predicate K962473.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSI

1in 2025

2007: 72008: 52009: 62010: 62011: 62012: 32013: 12014: 42015: 92016: 62018: 22019: 32020: 22023: 22024: 12025: 12026 (partial year): 1
2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007: 151 days median2008: 70 days median2009: 73 days median2010: 111 days median2011: 114 days median2012: 113 days median2014: 200 days median2015: 127 days median2016: 224 days median2019: 243 days median
2007high 243 (2019) · low 70 (2008)2026

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

Recalls per year · DSI

18in 2025

2007: 42008: 82009: 32010: 52011: 32012: 12018: 12019: 42020: 22022: 12023: 22025: 182026 (partial year): 1
2007high 18 (2025) · low 0 (2013)2026

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

Adverse event reports per year · DSI

712in 2025

2007: 642008: 1562009: 2792010: 8232011: 7932012: 7662013: 7952014: 1,0002015: 1,6452016: 4,3522017: 3,5942018: 3,6482019: 3,4852020: 3,0842021: 3,0922022: 1,6382023: 1,6162024: 1,3202025: 712
2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, 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
20077151464
20085708156
20096733279
201061115823
201161143793
201231131766
20131—0795
2014420001,000
2015912701,645
2016622404,352
20170—03,594
20182—13,648
2019324343,485
20202—23,084
20210—03,092
20220—11,638
20232—21,616
20241—01,320
20251—18712
20261—1—

What is it indicated for?

The Invivo Research Inc. The Centurion™ Central Station Arrhythmia Patient Monitoring is intended for general hospital or clinical use by medical professionals whenever it is required to monitor patients’ cardiac arrhythmias during ECG monitoring. The need to monitor these arrhythmias is most commonly encountered in the intensive care areas of the hospital during patient monitoring. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications..

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 K962473

1 other device cites the same predicate.

  • K020524Patientnet Monitoring SystemGeneral Electric Medical Systems Information Techn · 20021 recall

More from Invivo Research, Inc.

14 FDA decisions under this applicant name. See the company

  • K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
  • K043354Modular Telemetry System for the Vision Telepak, Model 20701Invivo Research, Inc. · 2005
  • K041918Integrated Patient Monitoring SystemInvivo Research, Inc. · 2004
  • K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
  • K002604Centurion 2000 Central Station Arrhythmia Patient Monitoring SystemInvivo Research, Inc. · 2002

Recent decisions in DSI

The DSI category page

  • K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026
  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
  • K231276SmartCardia 7L PlatformSmartcardia SA · 2023

https://510kreport.com/device/K980045 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980045: Centurion Central Station Arrhythmia Patient Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980045

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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