510(k) Report

510(k) · Cleared

Cleared

Models M1175A & M1176A Component Monitoring System

K882609510(k) TraditionalCleared Jan 19, 1989206-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

Waltham Div. Hewlett Packard · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Cleared on Jan 19, 1989 after a 206-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 504 later devices descend from it.

Decided
Jan 19, 1989
Review
206 days
Class
Class II
Product code
DRT
Recalls
None
Predicates
0

504 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2001: 2 descendants cleared1997: 1 descendant cleared2004: 14 descendants cleared2003: 6 descendants cleared2010: 28 descendants cleared1996: 1 descendant cleared2002: 6 descendants cleared2006: 22 descendants cleared2011: 22 descendants cleared2007: 9 descendants cleared2005: 15 descendants cleared2012: 20 descendants cleared2009: 24 descendants cleared2008: 16 descendants cleared2017: 21 descendants cleared2013: 20 descendants cleared1998: 1 descendant cleared2025: 29 descendants cleared2026: 20 descendants cleared2015: 19 descendants cleared2014: 22 descendants cleared2018: 25 descendants cleared2016: 21 descendants cleared2021: 21 descendants cleared2019: 20 descendants cleared1999: 1 descendant cleared2000: 1 descendant cleared2022: 29 descendants cleared2023: 27 descendants cleared2020: 14 descendants cleared2024: 27 descendants cleared1990200020102020
  1. This deviceK882609 Models M1175A & M1176A Component Monitoring SystemWaltham Div. Hewlett Packard · 1989
  2. Descendant · cites it directly · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  3. Descendant · 2 generations on · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  4. Descendant · 2 generations on · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  5. Descendant · 2 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  6. Descendant · 3 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002

Showing 5 of 504 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 11999: 12000: 12001: 22002: 62003: 62004: 142005: 152006: 222007: 92008: 162009: 242010: 282011: 222012: 202013: 202014: 222015: 192016: 212017: 212018: 252019: 202020: 142021: 212022: 292023: 272024: 272025: 292026: 20
1996high 29 (2022) · low 1 (1996)2026

Most influential descendants

Showing 5 of 504 · See all
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · cites it directly431descendants
  • K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · 2 generations on421descendants
  • K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems · 2002 · 2 generations on416descendants
  • K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · 2 generations on407descendants
  • K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · 3 generations on406descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K882609Models M1175A & M1176A Component Monitoring SystemWaltham Div. Hewlett Packard1989—
+1K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
+2K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002—
+2K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
+2K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
+3K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
199910
200010
200120
200260
200360
2004140
2005150
2006220
200790
2008160
2009240
2010280
2011220
2012200
2013200
2014220
2015190
2016210
2017210
2018250
2019200
2020140
2021210
2022290
2023270
2024270
2025290
2026200
FIG. 1 — Lineage of K882609, 1989–2026Source: 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? (504)

See all 504

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

NumberDeviceApplicantDecidedDescendants
K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc.2001431
K033444Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement ServerPhilips Medical Systems2003156
K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc.1997150
K032979Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc.200488
K042306Philips SP02 Disposable Sensor, Model M1131APhilips Medizin Systeme Boeblingen GmbH200476
K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037
K962115Cambridge Heart HI-Res Ecg ElectrodeCambridge Heart, Inc.19962
K013624Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient Monitors…Philips Medizin Systeme Boblingen GmbH20010

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, K013199 (Philips Medical Systems, Inc., 2001) has gone furthest, with 431 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—

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/K882609 · printed Nov 6, 2026

Cite this page

510(k) Report. “K882609: Models M1175A & M1176A Component 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/K882609

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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