510(k) Report

510(k) · Cleared

Cleared

HP M2600A Omnicare Telemetry System Model M2600A

K961165510(k) TraditionalCleared Oct 10, 1996199-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 Oct 10, 1996 as substantially equivalent to K894277 (Hewlett-Packard Co., 1989) after a 199-day review. Its family tree reaches back 1 generation to 1989. 27 later devices descend from it.

Decided
Oct 10, 1996
Review
199 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K894277 (1989). 27 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2012: 1 descendant cleared2008: 2 descendants cleared2014: 3 descendants cleared2015: 3 descendants cleared2017: 2 descendants cleared2016: 2 descendants cleared2019: 2 descendants cleared2020: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant cleared2026: 3 descendants cleared2025: 2 descendants cleared2024: 2 descendants clearedK894277 · M1400A Transmitter,M1402 Receiver,M1401 Mainframe · Hewlett-Packard Co. · 19891990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 5 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 4 descendants9 generations forward: 4 descendants10 generations forward: 2 descendants K894277 · M1400A Transmitter,M1402 Receiver,M1401 Mainframe · Hewlett-Packard Co. · 19890+5+10
  1. Root · 1 generation backK894277 M1400A Transmitter,M1402 Receiver,M1401 MainframeHewlett-Packard Co. · 1989
  2. This deviceK961165 HP M2600A Omnicare Telemetry System Model M2600AHewlett-Packard Co. · 1996
  3. Descendant · cites it directly · 26 of its ownK983996 Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999
  4. Descendant · 2 generations on · 20 of its ownK080192 Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · Recalled
  5. Descendant · 3 generations on · 17 of its ownK132036 Hypervisor Central Monitoring System (Including Telemetry Monitoring…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014
  6. Descendant · 4 generations on · 14 of its ownK150632 Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
  7. Descendant · 5 generations on · 12 of its ownK162607 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · Recalled

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

1999: 12008: 22012: 12014: 32015: 32016: 22017: 22019: 22020: 12022: 12023: 22024: 22025: 22026: 3
1999high 3 (2014) · low 0 (2000)2026

Most influential descendants

Showing 5 of 27 · See all
  • K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999 · cites it directly26descendants
  • K080192Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on20descendants
  • K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · 3 generations on17descendants
  • K150632Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 4 generations on14descendants
  • K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · 5 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K894277M1400A Transmitter,M1402 Receiver,M1401 MainframeHewlett-Packard Co.1989—
0 (this device)K961165HP M2600A Omnicare Telemetry System Model M2600AHewlett-Packard Co.1996—
+1K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc.1999—
+2K080192Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082
+3K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2014—
+4K150632Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20152
+5K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200820
201210
201430
201530
201620
201720
201920
202010
202210
202320
202420
202520
202630
FIG. 1 — Lineage of K961165, 1989–2026Source: 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 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? (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
*K894277M1400A Transmitter,M1402 Receiver,M1401 Mainframe
Summary page 1
…251 0CT 10 19% [510(K)] SUMMARY OF SAFETY AND EFFECTIVENESS This submission notifies the FDA of a our intention to replace the HP M1403A Telemetry Monitoring System, K894277 with a new system. The new system will be marketed as the HP M2600A OmniCare Telemetry System. The new system is very similar to…
Hewlett-Packard Co.1989—

Also cleared against K894277: 2 other devices →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc.199926

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, K983996 (Spacelabs Medical, Inc., 1999) has gone furthest, with 26 descendants of its own.
  • 2 other devices also cite its predicate K894277.

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 device is intended to provide ambulatory and nonambulatory monitoring of ECG and SpO, parameters of adult, and pediatric patients in a professional health care facility. It is intended to be used by trained health care personnel. It is not intended for home use.

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 K894277

2 other devices cite the same predicate.

  • K993516HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999
  • K980429HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care Telemetry System)Hewlett-Packard Co. · 1998

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/K961165 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961165: HP M2600A Omnicare Telemetry System Model M2600A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961165

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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