510(k) Report

510(k) · Cleared

Cleared

HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care Telemetry System)

K980429510(k) TraditionalCleared Sep 9, 1998217-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 Sep 9, 1998 as substantially equivalent to K894277 (Hewlett-Packard Co., 1989) and 3 other predicates after a 217-day review. Its family tree reaches back 1 generation to 1989. 337 later devices descend from it.

Decided
Sep 9, 1998
Review
217 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K894277 (1989). 4 ancestors in all. 337 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor1991: 2 other ancestors2003: 1 descendant cleared1999: 1 descendant cleared2014: 13 descendants cleared2017: 17 descendants cleared2015: 10 descendants cleared2010: 10 descendants cleared2011: 11 descendants cleared2001: 1 descendant cleared2004: 5 descendants cleared2007: 4 descendants cleared2005: 7 descendants cleared2006: 10 descendants cleared2009: 5 descendants cleared2008: 6 descendants cleared2016: 15 descendants cleared2018: 18 descendants cleared2012: 9 descendants cleared2013: 12 descendants cleared2024: 27 descendants cleared2023: 28 descendants cleared2022: 31 descendants cleared2020: 15 descendants cleared2026: 21 descendants cleared2025: 29 descendants cleared2021: 19 descendants cleared2019: 12 descendants clearedReference device: K961165 · HP M2600A Omnicare Telemetry System Model M2600A · Hewlett-Packard Co. · 1996K894277 · M1400A Transmitter,M1402 Receiver,M1401 Mainframe · Hewlett-Packard Co. · 19891990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 8 descendants3 generations forward: 32 descendants4 generations forward: 59 descendants5 generations forward: 48 descendants6 generations forward: 52 descendants7 generations forward: 54 descendants8 generations forward: 40 descendants9 generations forward: 19 descendants10 generations forward: 12 descendants11 generations forward: 8 descendants12 generations forward: 1 descendant13 generations forward: 1 descendant14 generations forward: 1 descendant 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 deviceK980429 HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A…Hewlett-Packard Co. · 1998
  3. Descendant · cites it directly · 336 of its ownK993516 HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999
  4. Descendant · 2 generations on · 260 of its ownK040357 M3290A Intellivue Information Center Software Release F.O and the…Philips Medical Systems, Inc. · 2004
  5. Descendant · 3 generations on · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  6. Descendant · 3 generations on · 251 of its ownK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  7. Descendant · 3 generations on · 250 of its ownK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 337 descendants. See all descendants

Descendants cleared per year

1999: 12001: 12003: 12004: 52005: 72006: 102007: 42008: 62009: 52010: 102011: 112012: 92013: 122014: 132015: 102016: 152017: 172018: 182019: 122020: 152021: 192022: 312023: 282024: 272025: 292026: 21
1999high 31 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 337 · See all
  • K993516HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999 · cites it directly336descendants
  • K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Philips Medical Systems, Inc. · 2004 · 2 generations on260descendants
  • K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · 3 generations on252descendants
  • K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2004 · 3 generations on251descendants
  • K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on250descendants
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)K980429HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care…Hewlett-Packard Co.1998—
+1K993516HP M2600A Viridia Telemetry SystemHewlett-Packard Co.1999—
+2K040357M3290A Intellivue Information Center Software Release F.O and the M4840A…Philips Medical Systems, Inc.2004—
+3K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
+3K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
+3K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200310
200450
200570
2006100
200740
200860
200950
2010100
2011110
201290
2013120
2014130
2015100
2016150
2017170
2018180
2019120
2020150
2021190
2022310
2023280
2024270
2025290
2026210
FIG. 1 — Lineage of K980429, 1989–2026Source: 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? (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
*K894277M1400A Transmitter,M1402 Receiver,M1401 Mainframe
Summary page 1
…at (978) 639-2529. 1.6 Date February 2, 1998 Regulatory Information 2.1 References 510(k) Notifications: = DC #K961165 - HP M2600DA OmniCare Telemetry System = DC #K894277 — HP M1403A 22 Device Name, Trade Name Proprietary: HP M2600A Viridia Telemetry System Common Name: HP Viridia Telemetry System.…
Hewlett-Packard Co.1989—
*K911139Hewlett-Packard Models M1400A, M1402A & M1401A
Summary page 1
…d below. MFG Device Models K# Hewlett-Packard Telemetry Monitoring System M1403A System K894277 Hewlett-Packard Telemetry Monitoring System, Revision 1.2 M1403A Systemn K911139 Hewlett-Packard Telemetry Monitoring System, added Analog Output M1403A System K913533 Hew!lett-Packard Telemetry Monitoring Syst…
Hewlett-Packard Co.1991—
*K913533Model M1403A Telemetry Monitoring Systems (TMS)
Summary page 1
…m K894277 Hewlett-Packard Telemetry Monitoring System, Revision 1.2 M1403A Systemn K911139 Hewlett-Packard Telemetry Monitoring System, added Analog Output M1403A System K913533 Hew!lett-Packard Telemetry Monitoring System, added ST monitoring M1403A System K920429 24 Products (Components) Included as Par…
Hewlett-Packard Co.1991—
*K920429Modified Model M1403A Telemetry Monitoring System
Summary page 1
…39 Hewlett-Packard Telemetry Monitoring System, added Analog Output M1403A System K913533 Hew!lett-Packard Telemetry Monitoring System, added ST monitoring M1403A System K920429 24 Products (Components) Included as Part of This Device: 2.6 Performance Standard: No accessories or additional None establishe…
Hewlett-Packard Co.1993—
†K961165HP M2600A Omnicare Telemetry System Model M2600AHewlett-Packard Co.1996—

Also cleared against K894277: 2 other devices →

What descends from it? (337)

See all 337

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

NumberDeviceApplicantDecidedDescendants
K993516HP M2600A Viridia Telemetry SystemHewlett-Packard Co.1999336
K023931Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727APhilips Medical Systems, Inc.200376

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K993516 (Hewlett-Packard Co., 1999) has gone furthest, with 336 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 indications for use of the Viridia Telemetry System are: « Condition: the licensed clinician decides that the Viridia Telemetry System should be used to monitor the patient. » Prescription versus over-the-counter: Viridia Telemetry System is a prescription device. « Part of body or type of tissue interacted with: The ECG signal is obtained from accessory electrodes in contact with the patient’s skin. The SpO; signal is obtained from an accessory…

Read the full statement (112 words)

The indications for use of the Viridia Telemetry System are:

« Condition: the licensed clinician decides that the Viridia Telemetry System should be used to monitor the patient.

» Prescription versus over-the-counter: Viridia Telemetry System is a prescription device.

« Part of body or type of tissue interacted with: The ECG signal is obtained from accessory electrodes in contact with the patient’s skin. The SpO; signal is obtained from an accessory sensor in contact with the patient’s skin.

« Frequency of use: As prescribed by licensed clinician.

« Physiological purpose: To monitor the ECG or Sp0O; of patients on the order of a licensed clinician.

« Patient population: Adult and pediatric patients.

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
  • K961165HP M2600A Omnicare Telemetry System Model M2600AHewlett-Packard Co. · 1996

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/K980429 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980429: HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care Telemetry System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980429

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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