510(k) · Cleared

Recalled · 2004

N-395 Pulse Oximeter, with Extended Device Claims

K993637510(k) SpecialCleared Nov 24, 199927-day reviewClass II21 CFR 870.2700Recalls 1

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 Nov 24, 1999 as substantially equivalent to K955642 (Nellcor Puritan Bennett, Inc., 1996) and 1 other predicate after a 27-day review. Its family tree reaches back 3 generations to 1997. 3 of the 720 devices in its family, counting itself, have a Class I recall. 715 later devices descend from it. It has been recalled once.

Decided: Nov 24, 1999
Review: 27 days
Class: Class II
Product code: DQA
Recalls: 1
Predicates: 2

Its longest line of descent runs back 3 generations to K962603 (1997). 4 ancestors in all, the oldest K955642 (1996). 715 later devices descend from it, 12 citing it directly. 3 of the 720 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
2 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
1 generation backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
This deviceK993637 N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc. · 1999
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
Descendant · 2 generations on · 426 of its ownK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
Descendant · 3 generations on · 290 of its ownK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
Descendant · cites it directly · 280 of its ownK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
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

Showing 5 of 715 descendants. See all descendants

Descendants cleared per year

2001high 47 (2025) · low 1 (2001)2026

Class I recalls in this family

K093261 MOVES2 generations on · 2010
K133576 Monitor B406 generations on · 2014
K123690 CAPNOSTREAM20P with Hifi C02 Monitoring8 generations on · 2014

Most influential descendants

Showing 5 of 715 · 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
K012451Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001 · cites it directly280descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
−2	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
−1	K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	1998	—
0 (this device)	K993637	N-395 Pulse Oximeter, with Extended Device Claims	Nellcor Puritan Bennett, Inc.	1999	—
+1	K012891	Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and…	Nellcor Puritan Bennett, Inc.	2002	1
+2	K021090	Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter	Nellcor Puritan Bennett, Inc.	2002	—
+3	K031740	VSM - Vital Signs Monitor, Model 53000 Series	Welch Allyn Protocol, Inc.	2003	—
+1	K012451	Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246	Welch Allyn Protocol, Inc.	2001	—
+2	K033048	Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…	Cas Medical Systems, Inc.	2004	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	8	0
2003	6	0
2004	11	0
2005	13	0
2006	14	0
2007	12	0
2008	19	0
2009	30	0
2010	27	1
2011	29	0
2012	34	0
2013	33	0
2014	34	2
2015	41	0
2016	32	0
2017	35	0
2018	40	0
2019	39	0
2020	35	0
2021	25	0
2022	43	0
2023	42	0
2024	35	0
2025	47	0
2026	30	0

FIG. 1 — Lineage of K993637, 1997–2026Source: 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.

3 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 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K955642	Nellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200 Display/Printer Summary page 1 …CLASSIFICATION: Class Il per 21 CFR 870.2700/74DQA Oximeter PREDICATE DEVICES: Predicate devices are as foliows: 1. N-3000 Pulse Oximeter, Nellcor Puritan Bennett Inc., K955642 2. Model 2000 Pulse Oximeter, Ivy Biomedical Systems, Inc., K882255 L DEVICE DESCRIPTION The N-395 Pulse Oximeter is manufactu…	Nellcor Puritan Bennett, Inc.	1996	—
*	K982255	Model 2000 Pulse Oximeter Our OCR of the scanned summary read K882255, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words.	Ivy Biomedical Systems, Inc.	1998	—
†	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—

Also cleared against K955642: 2 other devices →

What descends from it? (715)

See all 715

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

Number	Device	Applicant	Decided	Descendants
K012891	Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…	Nellcor Puritan Bennett, Inc.	2002	548
K012451	Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246	Welch Allyn Protocol, Inc.	2001	280
K022084	Atlas Monitor, Models 200,210,220	Welch Allyn, Inc.	2002	264
K031487	Model Avant 2120 Pulse Oximeter and Nibp	Nonin Medical, Inc.	2004	42
K100077	Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103	Solaris Medical Technology, Inc.	2010	22
K012706	IM2001 Pulse Oximeter	Imagyn Medical Technologies, Inc.	2003	2
K092549	Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P	Bio Medical Technologies Co., Ltd.	2009	1
K033973	Oxisensor II Recycled Sensor and Oximax Recycled Sensor	Nellcor Puritan Bennett, Inc.	2004	1
K211138	Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L)…	Stryker Sustainability Solutions	2022	0
K103584	Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…	Shenzhen Envisen Industry Co. Limited	2011	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 18, 2004	Not classified	Z-0665-05	Other	The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.

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.

K093261MOVESThornhill Research, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
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?

The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 11 months on median.
None of the 4 ancestors has a recall.
Of its descendants, K012891 (Nellcor Puritan Bennett, Inc., 2002) has gone furthest, with 548 descendants of its own.
2 other devices also cite its predicate K955642.

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 N-395 Pulse Oximeter is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities and intra-hospital transport environments. For prescription use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993637 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993637: N-395 Pulse Oximeter, with Extended Device Claims.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993637

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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