510(k) · Cleared

Cleared

Nellcor N-200 Pulse Oximeter, Model N-200

K022819510(k) SpecialCleared Sep 24, 200229-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 Puritan Bennett, Inc. · DQA Oximeter

Cleared on Sep 24, 2002 as substantially equivalent to K863784 (Nellcor, Inc., 1986) after a 29-day review. Its family tree reaches back 1 generation to 1986. 141 later devices descend from it.

Decided: Sep 24, 2002
Review: 29 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K863784 (1986). 141 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK863784 Nellcor N-200 (Pulse Oximeter)Nellcor, Inc. · 1986
This deviceK022819 Nellcor N-200 Pulse Oximeter, Model N-200Nellcor Puritan Bennett, Inc. · 2002
Descendant · cites it directly · 140 of its ownK060576 Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc. · 2006
Descendant · 2 generations on · 84 of its ownK090360 Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH · 2009
Descendant · 2 generations on · 53 of its ownK083325 N-600X with SPD, Oximax N-600XCovidien · 2009
Descendant · 3 generations on · 49 of its ownK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
Descendant · 2 generations on · 46 of its ownK120366 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012

Showing 5 of 141 descendants. See all descendants

Descendants cleared per year

2006high 16 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 141 · See all

K060576Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc. · 2006 · cites it directly140descendants
K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH · 2009 · 2 generations on84descendants
K083325N-600X with SPD, Oximax N-600XCovidien · 2009 · 2 generations on53descendants
K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012 · 3 generations on49descendants
K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · 2 generations on46descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K863784	Nellcor N-200 (Pulse Oximeter)	Nellcor, Inc.	1986	—
0 (this device)	K022819	Nellcor N-200 Pulse Oximeter, Model N-200	Nellcor Puritan Bennett, Inc.	2002	—
+1	K060576	Nellcor Oximax N-600X Pulse Oximeter	Nellcor Puritan Bennett, Inc.	2006	—
+2	K090360	Philips M3001A Multi Measurement Server	Philips Medizin Systeme Boblingen GmbH	2009	—
+2	K083325	N-600X with SPD, Oximax N-600X	Covidien	2009	—
+3	K111933	Covidien Nellcor Respiration Rate Software Application, Version 1.0	Covidien	2012	—
+2	K120366	Intellivue Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	2	0
2010	1	0
2011	3	0
2012	5	0
2013	6	0
2014	6	0
2015	10	0
2016	5	0
2017	9	0
2018	8	0
2019	9	0
2020	8	0
2021	3	0
2022	15	0
2023	11	0
2024	11	0
2025	16	0
2026	12	0

FIG. 1 — Lineage of K022819, 1986–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K863784	Nellcor N-200 (Pulse Oximeter) Summary page 1 …Pulse Oximeter Classification Name: Oximeter (74DQA) per 21 CFR $870.2700 Legally Marketed (Unmodified) Nellcor N-200 Pulse Oximeter, 5 1O(k) #K863 784 Device: Device Description The Nellcor N-200 Pulse Oximeter provides continuous non-invasive measurement and display of pulse ra…	Nellcor, Inc.	1986	—

Also cleared against K863784: 13 other devices →

What descends from it? (141)

See all 141

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

Number	Device	Applicant	Decided	Descendants
K060576	Nellcor Oximax N-600X Pulse Oximeter	Nellcor Puritan Bennett, Inc.	2006	140

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?

Its one ancestor has no recall.
Of its descendants, K060576 (Nellcor Puritan Bennett, Inc., 2006) has gone furthest, with 140 descendants of its own.
13 other devices also cite its predicate K863784.

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

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	122	6	325
2008	22	97	5	312
2009	35	117	29	281
2010	29	127	4	185
2011	15	195	1	164
2012	14	120	0	322
2013	15	182	0	468
2014	11	175	2	1,124
2015	13	158	1	2,082
2016	14	246	0	1,775
2017	9	200	0	1,190
2018	18	260	32	694
2019	19	158	0	548
2020	15	126	0	426
2021	10	174	0	553
2022	20	265	0	478
2023	13	317	0	392
2024	14	285	3	545
2025	15	182	0	399
2026	8	187	0	—

What is it indicated for?

The Nellcor N-200 pulse oximeter is intended for non-invasive, continuous, beat-by-beat

monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse

amplitude. This device is for prescription use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022819 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022819: Nellcor N-200 Pulse Oximeter, Model N-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022819

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026