510(k) · Cleared

Cleared

Lifesense, Model LS1-9R

K063752510(k) TraditionalCleared May 4, 2007136-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

Cleared on May 4, 2007 as substantially equivalent to K024300 (Oridion Medical 1987, Ltd., 2003) and 1 other predicate after a 136-day review. Its family tree reaches back 3 generations to 1995. 1 of the 17 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.

Decided: May 4, 2007
Review: 136 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K950387 (1995). 4 ancestors in all. 12 later devices descend from it, 3 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK950387 GeminiSpegas Industries, Ltd. · 1995
2 generations backK964239 Combination Oximeter/Carbon Dioxide Gas AnalyzerSpegas Industries, Ltd. · 1997
1 generation backK024300 Microcap Plus/NPB-75Oridion Medical 1987, Ltd. · 2003
This deviceK063752 Lifesense, Model LS1-9RNonin Medical, Inc. · 2007
Descendant · cites it directly · 7 of its ownK092101 Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009
Descendant · 2 generations on · 3 of its ownK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
Descendant · 2 generations on · 2 of its ownK172586 Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · Recalled
Descendant · cites it directly · 2 of its ownK093853 Single-Patient Use Disposable Sensor SeriesNonin Medical, Inc. · 2010
Descendant · 3 generations on · 1 of its ownK160865 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter…Nonin Medical, Inc. · 2016

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2009high 2 (2010) · low 0 (2012)2026

Class I recalls in this family

K970209 Capnocheck Plusdirect predicate · 1997

Most influential descendants

Showing 5 of 12 · See all

K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009 · cites it directly7descendants
K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · 2 generations on3descendants
K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · 2 generations on2descendants
K093853Single-Patient Use Disposable Sensor SeriesNonin Medical, Inc. · 2010 · cites it directly2descendants
K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc. · 2016 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K950387	Gemini	Spegas Industries, Ltd.	1995	—
−2	K964239	Combination Oximeter/Carbon Dioxide Gas Analyzer	Spegas Industries, Ltd.	1997	—
−1	K024300	Microcap Plus/NPB-75	Oridion Medical 1987, Ltd.	2003	—
0 (this device)	K063752	Lifesense, Model LS1-9R	Nonin Medical, Inc.	2007	—
+1	K092101	Reusable Pulse Oximeter Sensor, Model 8000 Series	Nonin Medical, Inc.	2009	—
+2	K132402	Sensmart Model X-100 Univeral Oximetry System	Nonin Medical, Inc.	2014	1
+2	K172586	Vios Monitoring System™ Model 2050	Vios Medical, Inc.	2018	4
+1	K093853	Single-Patient Use Disposable Sensor Series	Nonin Medical, Inc.	2010	—
+3	K160865	Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors…	Nonin Medical, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	2	0
2011	2	0
2014	1	0
2016	1	0
2018	1	0
2020	1	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K063752, 1995–2025Source: 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.

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 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
*	K024300	Microcap Plus/NPB-75 Summary page 1 …Plus/NPB-75 Capnograph/Pulse Oximeter manufactured by Oridion Medical, LTD cleared by the FDA under K024300 on 4/03/03 and the Capnocheck® Plus manufactured by BCI Inter…	Oridion Medical 1987, Ltd.	2003	—
*	K970209	Capnocheck Plus Summary page 1 …der K024300 on 4/03/03 and the Capnocheck® Plus manufactured by BCI International, Inc. cleared under K970209 on 4/18/97. Device Description: The LifeSense® Model LS1-9R is a lightweight, portable…	Bci Intl., Inc.	1997	Class I

Also cleared against K024300: 2 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K092101	Reusable Pulse Oximeter Sensor, Model 8000 Series	Nonin Medical, Inc.	2009	7
K093853	Single-Patient Use Disposable Sensor Series	Nonin Medical, Inc.	2010	2
K093306	Single-Patient Use Disposable Sensor	Nonin Medical, Inc.	2010	0

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.

K970209Capnocheck PlusBci Intl., Inc. · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K092101 (Nonin Medical, Inc., 2009) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K024300.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 LifeSense® Model LS1-9R Capnography/Pulse Oximeter monitor indicated for use in simultaneously measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (ETC0 2), respiration and pulse rate of well or poorly perfused adult, pediatric and infant patients. It is intended for use in environments where patients require continuous, non-invasive monitoring of these parameters by a healthcare professional, e.g. hospitals, medical facilities, post-operative care, patient transport, home-use, or any emergency medical services and environments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063752 · printed Nov 3, 2026

Cite this page

510(k) Report. “K063752: Lifesense, Model LS1-9R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K063752

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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