510(k) Report

510(k) · Cleared

Cleared

Nellcor (R) N-180 Pulse Oximeter

K913695510(k) TraditionalCleared Nov 13, 199186-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

Nellcor, Inc. · DQA Oximeter

Cleared on Nov 13, 1991 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 200 devices in its family, counting itself, has a Class I recall. 199 later devices descend from it.

Decided
Nov 13, 1991
Review
86 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

199 later devices descend from it, 6 citing it directly. 1 of the 200 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 5 descendants cleared1996: 2 descendants cleared1998: 2 descendants cleared2000: 2 descendants cleared1999: 2 descendants cleared2002: 6 descendants cleared2010: 12 descendants cleared2004: 3 descendants cleared2009: 11 descendants cleared2008: 8 descendants cleared2006: 7 descendants cleared2024: 9 descendants cleared2017: 13 descendants cleared2015: 14 descendants cleared2005: 3 descendants cleared2007: 6 descendants cleared2003: 1 descendant cleared2011: 5 descendants cleared2014: 12 descendants cleared, 1 with a Class I recall12012: 7 descendants cleared2013: 9 descendants cleared2021: 5 descendants cleared2016: 9 descendants cleared2020: 5 descendants cleared2018: 9 descendants cleared2022: 8 descendants cleared2019: 8 descendants cleared2023: 7 descendants cleared2026: 5 descendants cleared2025: 4 descendants cleared1990200020102020
  1. This deviceK913695 Nellcor (R) N-180 Pulse OximeterNellcor, Inc. · 1991
  2. Descendant · cites it directly · 150 of its ownK952912 Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc. · 1997
  3. Descendant · 2 generations on · 149 of its ownK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
  4. Descendant · 3 generations on · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
  5. Descendant · 4 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
  6. Descendant · 5 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005

Showing 5 of 199 descendants. See all descendants

Descendants cleared per year

1996: 21997: 51998: 21999: 22000: 22002: 62003: 12004: 32005: 32006: 72007: 62008: 82009: 112010: 122011: 52012: 72013: 92014: 122015: 142016: 92017: 132018: 92019: 82020: 52021: 52022: 82023: 72024: 92025: 42026: 5
1996high 14 (2015) · low 0 (2001)2026

Class I recalls in this family

  • K133576 Monitor B408 generations on · 2014

Most influential descendants

Showing 5 of 199 · See all
  • K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc. · 1997 · cites it directly150descendants
  • K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · 2 generations on149descendants
  • K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · 3 generations on119descendants
  • K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004 · 4 generations on88descendants
  • K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 5 generations on87descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913695Nellcor (R) N-180 Pulse OximeterNellcor, Inc.1991—
+1K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc.1997—
+2K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc.19983
+3K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp.20001
+4K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2004—
+5K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199750
199820
199920
200020
200260
200310
200430
200530
200670
200760
200880
2009110
2010120
201150
201270
201390
2014121
2015140
201690
2017130
201890
201980
202050
202150
202280
202370
202490
202540
202650
FIG. 1 — Lineage of K913695, 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.

1 device in this family has a Class I recall. 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (199)

See all 199

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

NumberDeviceApplicantDecidedDescendants
K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc.1997150
K955113Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc.199644
K970182Dinamap Compact MonitorJohnson & Johnson Medical, Inc.199741
K961450Score SoftwareNellcor Puritan Bennett, Inc.199613
K964978Vital Statistics System (O-Cath Accessory)Quinton, Inc.19970
K962781Corometrics Model 510 and 511 MonitorGe Medical Systems Information Technologies19970

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K952912 (Spacelabs Medical, Inc., 1997) has gone furthest, with 150 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 Nellcor, Inc.

18 FDA decisions under this applicant name. See the company

  • K953472Nellcor Symphony N-3100 Blood Pressure MonitorNellcor, Inc. · 1995
  • K952316Nellcor Symphony N-3000 Pulse OximeterNellcor, Inc. · 1995
  • K952222Nellcor N-20PA Portable Pulse OximeterNellcor, Inc. · 1995
  • K942347Nellcor Symphony Pulse Oximeter Model N-3000Nellcor, Inc. · 1995
  • K945947Nellcor Symphony (TM) N-3100 Blood Pressure Monitor and Connected to the Nellcor Symphony (TM) N-3000 Pulse…Nellcor, Inc. · 1995

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The DQA category page

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https://510kreport.com/device/K913695 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913695: Nellcor (R) N-180 Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913695

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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