510(k) · Cleared

Cleared

HP M2600A Viridia Telemetry System

K993516510(k) SpecialCleared Nov 8, 199921-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 Nov 8, 1999 as substantially equivalent to K894277 (Hewlett-Packard Co., 1989) and 5 other predicates after a 21-day review. Its family tree reaches back 2 generations to 1989. 336 later devices descend from it.

Decided: Nov 8, 1999
Review: 21 days
Class: Class II
Product code: DSI
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K894277 (1989). 6 ancestors in all. 336 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK894277 M1400A Transmitter,M1402 Receiver,M1401 MainframeHewlett-Packard Co. · 1989
1 generation backK980429 HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A…Hewlett-Packard Co. · 1998
This deviceK993516 HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999
Descendant · cites it directly · 260 of its ownK040357 M3290A Intellivue Information Center Software Release F.O and the…Philips Medical Systems, Inc. · 2004
Descendant · 2 generations on · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
Descendant · 2 generations on · 251 of its ownK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
Descendant · 2 generations on · 250 of its ownK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
Descendant · 2 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 336 descendants. See all descendants

Descendants cleared per year

2001high 31 (2022) · low 0 (2002)2026

Most influential descendants

Showing 5 of 336 · See all

K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Philips Medical Systems, Inc. · 2004 · cites it directly260descendants
K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · 2 generations on252descendants
K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2004 · 2 generations on251descendants
K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on250descendants
K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on249descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K894277	M1400A Transmitter,M1402 Receiver,M1401 Mainframe	Hewlett-Packard Co.	1989	—
−1	K980429	HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care…	Hewlett-Packard Co.	1998	—
0 (this device)	K993516	HP M2600A Viridia Telemetry System	Hewlett-Packard Co.	1999	—
+1	K040357	M3290A Intellivue Information Center Software Release F.O and the M4840A…	Philips Medical Systems, Inc.	2004	—
+2	K041235	Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors	Philips Medizin Systeme Boeblingen GmbH	2004	—
+2	K042845	The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…	Philips Medizin Systeme Boblingen GmbH	2004	—
+2	K050141	The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…	Philips Medizin Systeme Boeblingen GmbH	2005	—
+2	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…	Philips Medizin Systeme Boeblingen GmbH	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	2	0
1993	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2004	5	0
2005	7	0
2006	10	0
2007	4	0
2008	6	0
2009	5	0
2010	10	0
2011	11	0
2012	9	0
2013	12	0
2014	13	0
2015	10	0
2016	15	0
2017	17	0
2018	18	0
2019	12	0
2020	15	0
2021	19	0
2022	31	0
2023	28	0
2024	27	0
2025	29	0
2026	21	0

FIG. 1 — Lineage of K993516, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (6)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K894277	M1400A Transmitter,M1402 Receiver,M1401 Mainframe Summary page 2 …nt to Premarket Notification K980429. Additional predicate devices are listed below: Manufacturer Device Model 510(k) Hewlett Packard Telemetry Monitoring System M1403A K894277 Hewlett Packard Telemetry Monitoring System, Rev. 1.2 MI1403A K911139 Hewlett Packard Telemetry Monitoring System, added Analog O…	Hewlett-Packard Co.	1989	—
*	K911139	Hewlett-Packard Models M1400A, M1402A & M1401A Summary page 2 …listed below: Manufacturer Device Model 510(k) Hewlett Packard Telemetry Monitoring System M1403A K894277 Hewlett Packard Telemetry Monitoring System, Rev. 1.2 MI1403A K911139 Hewlett Packard Telemetry Monitoring System, added Analog Output M1403A K913533 Hewlett Packard Telemetry Monitoring System, adde…	Hewlett-Packard Co.	1991	—
*	K913533	Model M1403A Telemetry Monitoring Systems (TMS) Summary page 2 …oring System M1403A K894277 Hewlett Packard Telemetry Monitoring System, Rev. 1.2 MI1403A K911139 Hewlett Packard Telemetry Monitoring System, added Analog Output M1403A K913533 Hewlett Packard Telemetry Monitoring System, added ST monitoring M1403A K920429 Hewlett Packard M2600A Viridia Telemetry System M…	Hewlett-Packard Co.	1991	—
*	K920429	Modified Model M1403A Telemetry Monitoring System Summary page 2 …2 MI1403A K911139 Hewlett Packard Telemetry Monitoring System, added Analog Output M1403A K913533 Hewlett Packard Telemetry Monitoring System, added ST monitoring M1403A K920429 Hewlett Packard M2600A Viridia Telemetry System M2600A K980429 Hewlett Packard M2605A Viridia Wave Viewer M2605A K974567 8.0 Mod…	Hewlett-Packard Co.	1993	—
*	K980429	HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care Telemetry… Summary page 2 …l Equivalence The modified device is substantially equivalent to the previously cleared HP M2600A Viridia Telemetry System, marketed pursuant to Premarket Notification K980429. Additional predicate devices are listed below: Manufacturer Device Model 510(k) Hewlett Packard Telemetry Monitoring System M14…	Hewlett-Packard Co.	1998	—
*	K974567	Hewlett-Packard M2605A Viridia Wave Viewer Summary page 2 …ry Monitoring System, added ST monitoring M1403A K920429 Hewlett Packard M2600A Viridia Telemetry System M2600A K980429 Hewlett Packard M2605A Viridia Wave Viewer M2605A K974567 8.0 Modification Description The modification in this submission is the addition of a battery extender to enable the operation…	Hewlett-Packard Co.	1998	—

Also cleared against K894277: 2 other devices →

What descends from it? (336)

See all 336

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

Number	Device	Applicant	Decided	Descendants
K040357	M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…	Philips Medical Systems, Inc.	2004	260
K023931	Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A	Philips Medical Systems, Inc.	2003	76
K011824	Agilent M2636B Telemon B Monitor (Telemon B)	Agilent Technologies, Inc.	2001	0

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 10 years and passes through 1 company; a new generation was cleared every 9.0 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K040357 (Philips Medical Systems, Inc., 2004) has gone furthest, with 260 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

2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007high 243 (2019) · low 70 (2008)2026

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

Recalls per year · DSI

18in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	151	4	64
2008	5	70	8	156
2009	6	73	3	279
2010	6	111	5	823
2011	6	114	3	793
2012	3	113	1	766
2013	1	—	0	795
2014	4	200	0	1,000
2015	9	127	0	1,645
2016	6	224	0	4,352
2017	0	—	0	3,594
2018	2	—	1	3,648
2019	3	243	4	3,485
2020	2	—	2	3,084
2021	0	—	0	3,092
2022	0	—	1	1,638
2023	2	—	2	1,616
2024	1	—	0	1,320
2025	1	—	18	712
2026	1	—	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 vs. Over-The-Counter: The HP 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 (115 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 vs. Over-The-Counter: The HP 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 a licensed physician.

• Physiological purpose: To monitor the ECG or SpO; 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.

https://510kreport.com/device/K993516 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993516: HP M2600A Viridia Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993516

Report an extraction error

Are you the manufacturer?

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