510(k) Report

510(k) · Cleared

Cleared

Nellcor Symphony Pulse Oximeter Model N-3000

K942347510(k) TraditionalCleared May 12, 1995360-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 May 12, 1995 after a 360-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
May 12, 1995
Review
360 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 2 descendants cleared2006: 1 descendant cleared1995200020052010201520202025
  1. This deviceK942347 Nellcor Symphony Pulse Oximeter Model N-3000Nellcor, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK973147 NPB-295 Pulse OximeterNellcor Puritan Bennett, Inc. · 1997 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK052544 Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc. · 2006
  4. Descendant · cites it directly · 0 of its ownK972837 NPB-290 Pulse Oximeter (NPB-290)Nellcor Puritan Bennett, Inc. · 1997 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K973147NPB-295 Pulse OximeterNellcor Puritan Bennett, Inc. · 1997 · cites it directly1descendant
  • K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc. · 2006 · 2 generations on0descendants
  • K972837NPB-290 Pulse Oximeter (NPB-290)Nellcor Puritan Bennett, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942347Nellcor Symphony Pulse Oximeter Model N-3000Nellcor, Inc.1995—
+1K973147NPB-295 Pulse OximeterNellcor Puritan Bennett, Inc.19971
+2K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.2006—
+1K972837NPB-290 Pulse Oximeter (NPB-290)Nellcor Puritan Bennett, Inc.19971

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
200610
FIG. 1 — Lineage of K942347, 1995–2006Source: 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
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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? (3)

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

NumberDeviceApplicantDecidedDescendants
K973147NPB-295 Pulse OximeterNellcor Puritan Bennett, Inc.19971
K972837NPB-290 Pulse Oximeter (NPB-290)Nellcor Puritan Bennett, Inc.19970

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, K973147 (Nellcor Puritan Bennett, Inc., 1997) has gone furthest, with 1 descendant 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
  • K945947Nellcor Symphony (TM) N-3100 Blood Pressure Monitor and Connected to the Nellcor Symphony (TM) N-3000 Pulse…Nellcor, Inc. · 1995
  • K944760Dura-Y Oxygen Transducer, Ear ClipNellcor, Inc. · 1994

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https://510kreport.com/device/K942347 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942347: Nellcor Symphony Pulse Oximeter Model N-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942347

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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