510(k) Report

510(k) · Cleared

Cleared

Hewlett-Packard Models M1400A, M1402A & M1401A

K911139510(k) TraditionalCleared Jun 11, 199189-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. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Cleared on Jun 11, 1991 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 342 later devices descend from it.

Decided
Jun 11, 1991
Review
89 days
Class
Class II
Product code
DRT
Recalls
None
Predicates
0

342 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2003: 2 descendants cleared1999: 1 descendant cleared1998: 1 descendant cleared2004: 6 descendants cleared2008: 7 descendants cleared2001: 1 descendant 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 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 cleared1990200020102020
  1. This deviceK911139 Hewlett-Packard Models M1400A, M1402A & M1401AHewlett-Packard Co. · 1991
  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 342 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12001: 12002: 12003: 22004: 62005: 72006: 102007: 42008: 72009: 52010: 102011: 112012: 92013: 122014: 132015: 102016: 152017: 172018: 182019: 122020: 152021: 192022: 312023: 282024: 272025: 292026: 21
1998high 31 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 342 · 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)K911139Hewlett-Packard Models M1400A, M1402A & M1401AHewlett-Packard Co.1991—
+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
199810
199910
200110
200210
200320
200460
200570
2006100
200740
200870
200950
2010100
2011110
201290
2013120
2014130
2015100
2016150
2017170
2018180
2019120
2020150
2021190
2022310
2023280
2024270
2025290
2026210
FIG. 1 — Lineage of K911139, 1991–2026Source: 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 DRT? 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 DRT device

  1. #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (342)

See all 342

4 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
K012414Prime Ecg SystemMeridian Medical Technologies, Inc.20023
K030104Prime Ecg SystemMeridian Medical Technologies, Inc.20031

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 DRT devices

DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRT

1in 2025

2007: 12008: 12009: 62010: 32011: 32012: 12013: 12015: 12016: 12017: 12018: 12019: 12021: 22022: 12023: 12024: 32025: 12026 (partial year): 5
2007high 6 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRT

228in 2024

2009: 70 days median2010: 44 days median2011: 149 days median2024: 228 days median2026 (partial year): 120 days median
2007high 228 (2024) · low 44 (2010)2026

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

Recalls per year · DRT

1in 2024

2011: 12021: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DRT

40in 2025

2007: 1132008: 992009: 1182010: 632011: 362012: 472013: 162014: 262015: 482016: 552017: 1592018: 2242019: 4472020: 502021: 852022: 352023: 472024: 292025: 40
2007high 447 (2019) · low 16 (2013)2025

MAUDE reports naming product code DRT, 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
20071—0113
20081—099
20096700118
2010344063
20113149136
20121—047
20131—016
20140—026
20151—048
20161—055
20171—0159
20181—0224
20191—0447
20200—050
20212—185
20221—035
20231—047
20243228129
20251—040
202651200—

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 DRT

The DRT category page

  • K262447The Circadia CX00 System (CX00)Circadia Health, Inc. · 2026
  • K254058DistaSense (TM) (v1)Life Detection Technologies · 2026
  • K261286The Circadia C300 System (C300)Circadia Health, Inc. · 2026
  • K252676The Circadia C300 System (C300)Circadia Health, Inc. · 2026
  • K253388Sleepiz One+ (Model 2.5)Sleepiz AG · 2026

https://510kreport.com/device/K911139 · printed Nov 4, 2026

Cite this page

510(k) Report. “K911139: Hewlett-Packard Models M1400A, M1402A & M1401A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K911139

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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