510(k) Report

510(k) · Cleared

Cleared

HP Star ST and Arrhhythmia Software

K964122510(k) TraditionalCleared Jan 8, 199785-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

Hewlett-Packard Co. · DSI Detector And Alarm, Arrhythmia

Cleared on Jan 8, 1997 after an 85-day review. The FDA summary names no predicate by number. 456 later devices descend from it.

Decided
Jan 8, 1997
Review
85 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
0

456 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2007: 8 descendants cleared2010: 23 descendants cleared2001: 2 descendants cleared2008: 16 descendants cleared2016: 19 descendants cleared2002: 6 descendants cleared1999: 1 descendant cleared2004: 10 descendants cleared2015: 15 descendants cleared2005: 11 descendants cleared2003: 5 descendants cleared2006: 16 descendants cleared2011: 26 descendants cleared2009: 20 descendants cleared2013: 18 descendants cleared2012: 20 descendants cleared2017: 18 descendants cleared2018: 25 descendants cleared2014: 17 descendants cleared2025: 29 descendants cleared2026: 20 descendants cleared2021: 19 descendants cleared2022: 28 descendants cleared2020: 14 descendants cleared2023: 27 descendants cleared2019: 18 descendants cleared2024: 25 descendants cleared1995200020052010201520202025
  1. This deviceK964122 HP Star ST and Arrhhythmia SoftwareHewlett-Packard Co. · 1997
  2. Descendant · cites it directly · 455 of its ownK991773 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  3. Descendant · 2 generations on · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  4. Descendant · 3 generations on · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  5. Descendant · 3 generations on · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  6. Descendant · 3 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002

Showing 5 of 456 descendants. See all descendants

Descendants cleared per year

1999: 12001: 22002: 62003: 52004: 102005: 112006: 162007: 82008: 162009: 202010: 232011: 262012: 202013: 182014: 172015: 152016: 192017: 182018: 252019: 182020: 142021: 192022: 282023: 272024: 252025: 292026: 20
1999high 29 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 456 · See all
  • K991773HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH · 1999 · cites it directly455descendants
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · 2 generations on431descendants
  • K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · 3 generations on421descendants
  • K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems · 2002 · 3 generations on416descendants
  • K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · 3 generations on407descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K964122HP Star ST and Arrhhythmia SoftwareHewlett-Packard Co.1997—
+1K991773HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
+2K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
+3K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002—
+3K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
+3K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200120
200260
200350
2004100
2005110
2006160
200780
2008160
2009200
2010230
2011260
2012200
2013180
2014170
2015150
2016190
2017180
2018250
2019180
2020140
2021190
2022280
2023270
2024250
2025290
2026200
FIG. 1 — Lineage of K964122, 1997–2026Source: 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 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (456)

See all 456

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

NumberDeviceApplicantDecidedDescendants
K991773HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999455
K014261ST/AR ST and Arrhythmia Software, Model Release E.0Philips Medical Systems, Inc.2002263
K021251ST/AR ST and Arrhythmia Software, Release E.I.Philips Medical Systems2002262
K070260Star ST and Arrhythmia Software, Release H.0Philips Medical Systems20077
K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086
K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104
K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160
K011824Agilent M2636B Telemon B Monitor (Telemon B)Agilent Technologies, Inc.20010

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?

  • Of its descendants, K991773 (Hewlett-Packard GmbH, 1999) has gone furthest, with 455 descendants of its own.

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 indications for use of the STAR ST and Arrhythmia algorithm software device are:

Condition: the clinician decides to continuously monitor cardiac arrhythmia and / or ST segment.

Part of body or type of tissue interacted with: ECG signal obtained from electrodes attached to the skin of adult, pediatric, and neonatal patients

Frequency of use: As prescribed by clinician.

Physiological purpose: To gain information for treatment or to rule out causes of symptoms.

Prescription versus over-the-counter: STAR is a prescription device

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

More from Hewlett-Packard Co.

230 FDA decisions under this applicant name. See the company

  • K992543Heartstream XLT Defibrillator/Monitor, AC Charger, DC Charger, Data Card, Single Bay Adapter, Defibrillator…Hewlett-Packard Co. · 2000
  • K993587HP M2376A Device Link SystemHewlett-Packard Co. · 2000
  • K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co. · 1999
  • K992977Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504AHewlett-Packard Co. · 1999
  • K993516HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999

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/K964122 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964122: HP Star ST and Arrhhythmia Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964122

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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