510(k) Report

510(k) · Cleared

Cleared

Hewlett-Packard M2605A Viridia Wave Viewer

K974567510(k) TraditionalCleared Jan 20, 199846-day reviewClass II21 CFR 870.2300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hewlett-Packard Co. · MSX System, Network And Communication, Physiological Monitors

Cleared on Jan 20, 1998 after a 46-day review. The FDA summary names no predicate by number. 337 later devices descend from it.

Decided
Jan 20, 1998
Review
46 days
Class
Class II
Product code
MSX
Recalls
None
Predicates
0

337 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared1999: 1 descendant cleared2003: 1 descendant cleared2004: 5 descendants cleared2014: 13 descendants cleared2017: 17 descendants cleared2015: 10 descendants cleared2010: 10 descendants cleared2011: 11 descendants cleared2007: 4 descendants cleared2005: 7 descendants cleared2006: 10 descendants cleared2009: 5 descendants cleared2008: 6 descendants cleared2012: 9 descendants cleared2013: 12 descendants cleared2016: 15 descendants cleared2018: 18 descendants cleared2021: 19 descendants cleared2020: 15 descendants cleared2023: 28 descendants cleared2022: 31 descendants cleared2024: 27 descendants cleared2026: 21 descendants cleared2025: 29 descendants cleared2019: 12 descendants clearedReference device: K945277 · Hewlett-Packard Model M1490A Wireless Patient Data Communicator · Hewlett-Packard Co. · 1995Reference device: K961165 · HP M2600A Omnicare Telemetry System Model M2600A · Hewlett-Packard Co. · 1996Reference device: K922974 · Portable Patient Monitor · Hewlett-Packard Co. · 1992Reference device: K945134 · Portable Patient Monitor · Hewlett-Packard Co. · 1994Reference device: K923343 · Hewlett-Packard Model M1020A Pulse Oximeter · Hewlett-Packard Co. · 19931995200020052010201520202025
  1. This deviceK974567 Hewlett-Packard M2605A Viridia Wave ViewerHewlett-Packard Co. · 1998
  2. Descendant · cites it directly · 336 of its ownK993516 HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999
  3. Descendant · 2 generations on · 260 of its ownK040357 M3290A Intellivue Information Center Software Release F.O and the…Philips Medical Systems, Inc. · 2004
  4. Descendant · 3 generations on · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  5. 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
  6. 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
0 (this device)K974567Hewlett-Packard M2605A Viridia Wave ViewerHewlett-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—

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 K974567, 1998–2026Source: 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 MSX? 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 MSX device

  1. #1 K242750 Central Stationscore 21.5 · 31 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? (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
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, K993516 (Hewlett-Packard Co., 1999) has gone furthest, with 336 descendants of its own.

How does its category compare?

All MSX devices

MSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MSX

4in 2025

2007: 42008: 12009: 12010: 32011: 72012: 42013: 22014: 32015: 52016: 32017: 22018: 42019: 42020: 52021: 32022: 52023: 32024: 42025: 42026 (partial year): 5
2007high 7 (2011) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSX

295in 2025

2007: 58 days median2010: 43 days median2011: 72 days median2012: 145 days median2014: 165 days median2015: 138 days median2016: 174 days median2018: 111 days median2019: 92 days median2020: 193 days median2021: 227 days median2022: 177 days median2023: 244 days median2024: 212 days median2025: 295 days median2026 (partial year): 145 days median
2007high 295 (2025) · low 43 (2010)2026

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

Recalls per year · MSX

1in 2025

2007: 12008: 12009: 22010: 12011: 12012: 22015: 22017: 22018: 12022: 12025: 12026 (partial year): 2
2007high 2 (2009) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MSX

19in 2025

2007: 52008: 62009: 72010: 142011: 32012: 42013: 172014: 322015: 312016: 112017: 162018: 152019: 152020: 252021: 172022: 182023: 102024: 322025: 19
2007high 32 (2014) · low 3 (2011)2025

MAUDE reports naming product code MSX, 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
200745815
20081—16
20091—27
2010343114
201177213
2012414524
20132—017
20143165032
20155138231
20163174011
20172—216
20184111115
2019492015
20205193025
20213227017
20225177118
20233244010
20244212032
20254295119
202651452—

What is it indicated for?

The device is intended to be used as an assessment tool that enables licensed clinicians in a clinical environment to determine the quality of ECG and SpO2 signals at the location of telemetry monitored patients. In addition, limited assessment of patients ECG and SpO2 vital signs can be determined. Viridia Wave Viewer is not intended for monitoring and has no alarm functions. The device is not intended for home use and is not suitable for patient monitoring.

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

Cite this page

510(k) Report. “K974567: Hewlett-Packard M2605A Viridia Wave Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974567

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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