510(k) Report

510(k) · Cleared

Cleared

Acuity Central Station

K972121510(k) TraditionalCleared Nov 7, 1997155-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

Protocol Systems, Inc. · MLD Monitor, St Segment With Alarm

Cleared on Nov 7, 1997 as substantially equivalent to K925411 (Accucore, Inc., 1993) after a 155-day review. Its family tree reaches back 1 generation to 1993. 64 later devices descend from it.

Decided
Nov 7, 1997
Review
155 days
Class
Class II
Product code
MLD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K925411 (1993). 64 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2005: 1 descendant cleared2003: 1 descendant cleared2010: 1 descendant cleared2006: 1 descendant cleared2012: 4 descendants cleared2007: 2 descendants cleared2015: 8 descendants cleared2014: 3 descendants cleared2011: 1 descendant cleared2013: 2 descendants cleared2020: 2 descendants cleared2016: 3 descendants cleared2019: 3 descendants cleared2018: 6 descendants cleared2022: 5 descendants cleared2017: 1 descendant cleared2021: 2 descendants cleared2025: 8 descendants cleared2023: 3 descendants cleared2024: 2 descendants cleared2026: 4 descendants clearedK925411 · Model 2041-PC/ST Cardiac Telemetry Monitor · Accucore, Inc. · 19931990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 9 descendants3 generations forward: 8 descendants4 generations forward: 10 descendants5 generations forward: 12 descendants6 generations forward: 12 descendants7 generations forward: 8 descendants8 generations forward: 3 descendants K925411 · Model 2041-PC/ST Cardiac Telemetry Monitor · Accucore, Inc. · 19930+5
  1. Root · 1 generation backK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
  2. This deviceK972121 Acuity Central StationProtocol Systems, Inc. · 1997
  3. Descendant · cites it directly · 63 of its ownK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
  4. Descendant · cites it directly · 38 of its ownK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · Recalled
  5. Descendant · 2 generations on · 20 of its ownK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
  6. Descendant · 3 generations on · 18 of its ownK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
  7. Descendant · 4 generations on · 17 of its ownK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12005: 12006: 12007: 22010: 12011: 12012: 42013: 22014: 32015: 82016: 32017: 12018: 62019: 32020: 22021: 22022: 52023: 32024: 22025: 82026: 4
2002high 8 (2015) · low 0 (2004)2026

Most influential descendants

Showing 5 of 64 · See all
  • K022453Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · cites it directly63descendants
  • K052160Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · cites it directly38descendants
  • K122036Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · 2 generations on20descendants
  • K133586Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013 · 3 generations on18descendants
  • K143751Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 4 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K925411Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc.1993—
0 (this device)K972121Acuity Central StationProtocol Systems, Inc.1997—
+1K022453Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc.20021
+1K052160Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc.20052
+2K122036Visi Mobile Monitoring SystemSotera Wireless, Inc.20122
+3K133586Visi Mobile Monitioring SystemSotera Wireless, Inc.2013—
+4K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200510
200610
200720
201010
201110
201240
201320
201430
201580
201630
201710
201860
201930
202020
202120
202250
202330
202420
202580
202640
FIG. 1 — Lineage of K972121, 1993–2026Source: 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 MLD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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
*K925411Model 2041-PC/ST Cardiac Telemetry Monitor
Summary page 1
…997 Predicate Device: “Cardiac Central Station Monitor with ST Segment Analysis” (PCI Model 2041-PC/ST, Pacific Communications, Inc. (PCIL, now VitalCom), 510(k) Number K925411/A) Device Name: Acuity Central Station Classification Name: System, ECG Analysis (ST), Class III under section 513 of the Federa…
Accucore, Inc.1993—

Also cleared against K925411: 1 other device →

What descends from it? (64)

See all 64

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022453Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc.200263
K052160Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc.200538

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, K022453 (Welch Allyn Protocol, Inc., 2002) has gone furthest, with 63 descendants of its own.
  • 1 other device also cites its predicate K925411.

How does its category compare?

All MLD devices

MLD Monitor, St Segment With Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MLD

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MLD

Too few MLD 510(k)s in any year since 2007 to give a median.

Recalls per year · MLD

No recall names MLD since 2007.

Adverse event reports per year · MLD

1in 2019

2007: 32008: 52009: 32010: 32011: 62012: 72014: 12015: 12017: 12018: 12019: 1
2007high 7 (2012) · low 0 (2013)2025

MAUDE reports naming product code MLD, 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
20070—03
20081—05
20090—03
20101—03
20110—06
20120—07
20130—00
20140—01
20150—01
20160—00
20170—01
20180—01
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Acuity ST Analysis option is being incorporated into the Acuity central station (licensed with Arrhythmia and Full Disclosure) as part of a network system within the hospital environment or clinical setting. The ST Analysis option is intended to be used to provide real-time monitoring and alarms for ST segment deviations (from a reference beat) for patients with suspected heart disease or anomalies. It is recommended for use with Adult and Pediatric…

Read the full statement (173 words)

The Acuity ST Analysis option is being incorporated into the Acuity central station (licensed with Arrhythmia and Full Disclosure) as part of a network system within the hospital environment or clinical setting. The ST Analysis option is intended to be used to provide real-time monitoring and alarms for ST segment deviations (from a reference beat) for patients with suspected heart disease or anomalies.

It is recommended for use with Adult and Pediatric patients one year or older. ST Analysis is automatically disabled when the corresponding Propaq Encore is in the Neonatal patient mode.

It is intended for use by healthcare practitioners who know how to acquire and interpret patients’ vital signs and are trained in the use of the Acuity System and its components. The clinician is responsible for determining the clinical significance of each alarm generated by Acuity. As with all computerized ST Analysis systems, Acuity cannot replace skilled care and proper surveillance by a clinician. A clinician should review all data obtained from Acuity before implementing therapy based on this data.

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 K925411

1 other device cites the same predicate.

  • K980045Centurion Central Station Arrhythmia Patient Monitoring SystemInvivo Research, Inc. · 1998

More from Protocol Systems, Inc.

15 FDA decisions under this applicant name. See the company

  • K002725Micropaq, Models 402 and 404Protocol Systems, Inc. · 2000
  • K951246Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography OptionsProtocol Systems, Inc. · 1996
  • K945071Propaq 200 MonitorProtocol Systems, Inc. · 1995
  • K935846Model Acuity Central StationProtocol Systems, Inc. · 1994
  • K934711Propaq Ecg Telemetry OptionProtocol Systems, Inc. · 1994

Recent decisions in MLD

The MLD category page

  • K101602Vital Signs MonitorCriticare Systems, Inc. · 2010
  • K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008
  • K022740Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A SoftwareDatex-Ohmeda · 20022 recalls
  • K012837Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and AccessoriesDatex-Ohmeda · 20012 recalls
  • K002105Siemens Infinity SC 6002XL Enhanced with ST Segment AnalysisSiemens Medical Solutions USA, Inc. · 2000

https://510kreport.com/device/K972121 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972121: Acuity Central Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972121

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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