510(k) Report

510(k) · Cleared

Cleared

Modified Model M1403A Telemetry Monitoring System

K920429510(k) TraditionalCleared Jul 20, 1993533-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. · MLD Monitor, St Segment With Alarm

Cleared on Jul 20, 1993 after a 533-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 441 later devices descend from it.

Decided
Jul 20, 1993
Review
533 days
Class
Class II
Product code
MLD
Recalls
None
Predicates
0

441 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared1999: 2 descendants cleared2015: 15 descendants cleared2010: 12 descendants cleared2008: 8 descendants cleared2003: 2 descendants cleared2014: 15 descendants cleared2004: 6 descendants cleared2001: 1 descendant cleared2017: 22 descendants cleared2011: 13 descendants cleared2009: 6 descendants cleared2006: 11 descendants cleared2012: 12 descendants cleared2007: 4 descendants cleared2005: 7 descendants cleared2013: 14 descendants cleared2016: 19 descendants cleared2019: 20 descendants cleared2023: 40 descendants cleared2018: 25 descendants cleared2021: 23 descendants cleared2020: 22 descendants cleared2022: 37 descendants cleared2024: 34 descendants cleared2026: 27 descendants cleared2025: 42 descendants cleared1990200020102020
  1. This deviceK920429 Modified Model M1403A Telemetry Monitoring SystemHewlett-Packard Co. · 1993
  2. Descendant · cites it directly · 337 of its ownK980429 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

Showing 5 of 441 descendants. See all descendants

Descendants cleared per year

1998: 21999: 22001: 12003: 22004: 62005: 72006: 112007: 42008: 82009: 62010: 122011: 132012: 122013: 142014: 152015: 152016: 192017: 222018: 252019: 202020: 222021: 232022: 372023: 402024: 342025: 422026: 27
1998high 42 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 441 · See all
  • K980429HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care Telemetry…Hewlett-Packard Co. · 1998 · cites it directly337descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920429Modified Model M1403A Telemetry Monitoring SystemHewlett-Packard Co.1993—
+1K980429HP 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199920
200110
200320
200460
200570
2006110
200740
200880
200960
2010120
2011130
2012120
2013140
2014150
2015150
2016190
2017220
2018250
2019200
2020220
2021230
2022370
2023400
2024340
2025420
2026270
FIG. 1 — Lineage of K920429, 1993–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MLD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (441)

See all 441

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

NumberDeviceApplicantDecidedDescendants
K980429HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care Telemetry…Hewlett-Packard Co.1998337
K993516HP M2600A Viridia Telemetry SystemHewlett-Packard Co.1999336
K974149Ambulatory X-12 Telemetry ModuleMortara Instrument, Inc.1998122

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, K980429 (Hewlett-Packard Co., 1998) has gone furthest, with 337 descendants of its own.

How does its category compare?

All MLD devices

MLD Monitor, St Segment With Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MLD

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MLD

Too few MLD 510(k)s in any year since 2007 to give a median.

Recalls per year · MLD

No recall names MLD since 2007.

Adverse event reports per year · MLD

1in 2019

2007: 32008: 52009: 32010: 32011: 62012: 72014: 12015: 12017: 12018: 12019: 1
2007high 7 (2012) · low 0 (2013)2025

MAUDE reports naming product code MLD, 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
20070—03
20081—05
20090—03
20101—03
20110—06
20120—07
20130—00
20140—01
20150—01
20160—00
20170—01
20180—01
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

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 MLD

The MLD category page

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https://510kreport.com/device/K920429 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920429: Modified Model M1403A Telemetry Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920429

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026