510(k) Report

510(k) · Cleared

Cleared

Nellcor N-20PA Portable Pulse Oximeter

K952222510(k) TraditionalCleared Aug 15, 199595-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 Aug 15, 1995 after a 95-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 550 devices in its family, counting itself, have a Class I recall. 549 later devices descend from it.

Decided
Aug 15, 1995
Review
95 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

549 later devices descend from it, 1 citing it directly. 2 of the 550 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2002: 7 descendants cleared2007: 8 descendants cleared2022: 38 descendants cleared2005: 12 descendants cleared2009: 21 descendants cleared2004: 9 descendants cleared2003: 4 descendants cleared2006: 7 descendants cleared2013: 28 descendants cleared2014: 27 descendants cleared, 2 with a Class I recall22008: 12 descendants cleared2017: 27 descendants cleared2015: 35 descendants cleared2010: 22 descendants cleared2012: 27 descendants cleared2011: 20 descendants cleared2019: 27 descendants cleared2016: 25 descendants cleared2018: 31 descendants cleared2021: 22 descendants cleared2020: 22 descendants cleared2026: 24 descendants cleared2025: 31 descendants cleared2023: 33 descendants cleared2024: 30 descendants cleared1995200020052010201520202025
  1. This deviceK952222 Nellcor N-20PA Portable Pulse OximeterNellcor, Inc. · 1995
  2. Descendant · cites it directly · 548 of its ownK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 426 of its ownK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
  4. Descendant · 3 generations on · 290 of its ownK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
  5. Descendant · 2 generations on · 272 of its ownK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
  6. Descendant · 2 generations on · 264 of its ownK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005

Showing 5 of 549 descendants. See all descendants

Descendants cleared per year

2002: 72003: 42004: 92005: 122006: 72007: 82008: 122009: 212010: 222011: 202012: 272013: 282014: 272015: 352016: 252017: 272018: 312019: 272020: 222021: 222022: 382023: 332024: 302025: 312026: 24
2002high 38 (2022) · low 4 (2003)2026

Class I recalls in this family

  • K133576 Monitor B406 generations on · 2014
  • K123690 CAPNOSTREAM20P with Hifi C02 Monitoring8 generations on · 2014

Most influential descendants

Showing 5 of 549 · See all
  • K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Nellcor Puritan Bennett, Inc. · 2002 · cites it directly548descendants
  • K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002 · 2 generations on426descendants
  • K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003 · 3 generations on290descendants
  • K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc. · 2004 · 2 generations on272descendants
  • K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc. · 2005 · 2 generations on264descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952222Nellcor N-20PA Portable Pulse OximeterNellcor, Inc.1995—
+1K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and…Nellcor Puritan Bennett, Inc.20021
+2K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc.2002—
+3K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc.2003—
+2K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…Cas Medical Systems, Inc.20041
+2K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL…Cas Medical Systems, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200270
200340
200490
2005120
200670
200780
2008120
2009210
2010220
2011200
2012270
2013280
2014272
2015350
2016250
2017270
2018310
2019270
2020220
2021220
2022380
2023330
2024300
2025310
2026240
FIG. 1 — Lineage of K952222, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

2 devices in this family have 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (549)

See all 549

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Nellcor Puritan Bennett, Inc.2002548

Has anything in its family been recalled? (2 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 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
  • K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K012891 (Nellcor Puritan Bennett, Inc., 2002) has gone furthest, with 548 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
  • 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
  • K944760Dura-Y Oxygen Transducer, Ear ClipNellcor, Inc. · 1994

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • 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/K952222 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952222: Nellcor N-20PA Portable Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952222

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026