510(k) Report

510(k) · Cleared

Cleared

HP Model M1020A, Arterial Oxygen Sat/Pleth Module

K903523510(k) TraditionalCleared Oct 23, 199078-day reviewClass II21 CFR 870.2700

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

Hewlett-Packard Co. · DQA Oximeter

Cleared on Oct 23, 1990 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 463 later devices descend from it.

Decided
Oct 23, 1990
Review
78 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2010: 25 descendants cleared1999: 1 descendant cleared2011: 26 descendants cleared2013: 18 descendants cleared2003: 5 descendants cleared2005: 13 descendants cleared2004: 12 descendants cleared2001: 1 descendant cleared2002: 4 descendants cleared2006: 17 descendants cleared2009: 20 descendants cleared2007: 7 descendants cleared2008: 16 descendants cleared2012: 20 descendants cleared2015: 16 descendants cleared2025: 29 descendants cleared2026: 20 descendants cleared2018: 25 descendants cleared2017: 19 descendants cleared2016: 20 descendants cleared2014: 17 descendants cleared2023: 27 descendants cleared2020: 14 descendants cleared2022: 28 descendants cleared2021: 19 descendants cleared2019: 18 descendants cleared2024: 26 descendants cleared1990200020102020
  1. This deviceK903523 HP Model M1020A, Arterial Oxygen Sat/Pleth ModuleHewlett-Packard Co. · 1990
  2. Descendant · cites it directly · 462 of its ownK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  3. Descendant · 2 generations on · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  4. Descendant · 3 generations on · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  5. Descendant · 3 generations on · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  6. Descendant · 3 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002

Showing 5 of 463 descendants. See all descendants

Descendants cleared per year

1999: 12001: 12002: 42003: 52004: 122005: 132006: 172007: 72008: 162009: 202010: 252011: 262012: 202013: 182014: 172015: 162016: 202017: 192018: 252019: 182020: 142021: 192022: 282023: 272024: 262025: 292026: 20
1999high 29 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 463 · See all
  • K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH · 1999 · cites it directly462descendants
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · 2 generations on431descendants
  • K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · 3 generations on421descendants
  • K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems · 2002 · 3 generations on416descendants
  • K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · 3 generations on407descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903523HP Model M1020A, Arterial Oxygen Sat/Pleth ModuleHewlett-Packard Co.1990—
+1K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
+2K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
+3K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002—
+3K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
+3K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200240
200350
2004120
2005130
2006170
200770
2008160
2009200
2010250
2011260
2012200
2013180
2014170
2015160
2016200
2017190
2018250
2019180
2020140
2021190
2022280
2023270
2024260
2025290
2026200
FIG. 1 — Lineage of K903523, 1990–2026Source: 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 DQA? 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 DQA device

  1. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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?

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

What descends from it? (463)

See all 463

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

NumberDeviceApplicantDecidedDescendants
K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999462
K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037

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, K990972 (Hewlett-Packard GmbH, 1999) has gone furthest, with 462 descendants of its own.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

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

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

More from Hewlett-Packard Co.

230 FDA decisions under this applicant name. See the company

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  • 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

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The DQA category page

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  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K903523 · printed Nov 5, 2026

Cite this page

510(k) Report. “K903523: HP Model M1020A, Arterial Oxygen Sat/Pleth Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903523

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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