510(k) · Cleared

Cleared

Capnostream 20 with A2 Adaptive Averaging Software

K072295510(k) SpecialCleared Oct 11, 200756-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

Oridion Capnography, Inc. · DQA Oximeter

Cleared on Oct 11, 2007 as substantially equivalent to K060065 (Oridion Capnography, Inc., 2006) after a 56-day review. Its family tree reaches back 9 generations to 1997. 2 of the 233 devices in its family, counting itself, have a Class I recall. 197 later devices descend from it.

Decided: Oct 11, 2007
Review: 56 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 9 generations to K962603 (1997). 35 ancestors in all, the oldest K893221 (1990). 197 later devices descend from it, 3 citing it directly. 2 of the 233 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
5 generations between
3 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
2 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
1 generation backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
This deviceK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
Descendant · cites it directly · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
Descendant · 2 generations on · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
Descendant · 3 generations on · 115 of its ownK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
Descendant · 2 generations on · 93 of its ownK094012 CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010
Descendant · 4 generations on · 89 of its ownK110028 Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011

Show all 9 generations

Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
5 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
4 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
3 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
2 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
1 generation backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
This deviceK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007

Showing 5 of 197 descendants. See all descendants

Descendants cleared per year

2008high 19 (2022) · low 1 (2008)2026

Class I recalls in this family

K970209 Capnocheck Plus4 generations back · 1997
K123690 CAPNOSTREAM20P with Hifi C02 Monitoring5 generations on · 2014

Most influential descendants

Showing 5 of 197 · See all

K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · cites it directly170descendants
K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · 2 generations on155descendants
K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010 · 3 generations on115descendants
K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010 · 2 generations on93descendants
K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011 · 4 generations on89descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
−8	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
−7	K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	1998	—
−6	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—
−5	K012891	Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and…	Nellcor Puritan Bennett, Inc.	2002	1
−4	K021090	Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter	Nellcor Puritan Bennett, Inc.	2002	—
−3	K033048	Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…	Cas Medical Systems, Inc.	2004	1
−2	K050844	750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL…	Cas Medical Systems, Inc.	2005	—
−1	K060065	CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…	Oridion Capnography, Inc.	2006	3
0 (this device)	K072295	Capnostream 20 with A2 Adaptive Averaging Software	Oridion Capnography, Inc.	2007	—
+1	K082268	CAPNOSTREAM20 with Integrated Pulmonary Index	Oridion Capnography, Inc.	2009	9
+2	K091241	Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter	Masimo Corporation	2009	—
+3	K100428	Masimo Rainbow Set Radical 7R Pulse CO-Oximeter	Masimo Corporation	2010	—
+2	K094012	CAPNOSTREAM20 with MICROMEDICO2 Module	Oridion Capnography, Inc.	2010	—
+4	K110028	Masimo Radical Y Pulse CO-Oximeter	Masimo Corporation	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	2	0
1991	2	0
1992	1	0
1993	1	0
1995	4	0
1996	2	0
1997	2	1
1998	4	0
1999	3	0
2000	1	0
2002	1	0
2003	1	0
2004	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	3	0
2010	4	0
2011	5	0
2012	8	0
2013	10	0
2014	15	1
2015	10	0
2016	7	0
2017	9	0
2018	11	0
2019	15	0
2020	13	0
2021	8	0
2022	19	0
2023	14	0
2024	16	0
2025	16	0
2026	13	0

FIG. 1 — Lineage of K072295, 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.

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 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
*	K060065	CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor Summary page 2 …ercially available device: Manufacturer Device 510(k)No. Clearance Date Oridion 1987 Medical Capnostream 20 K060065 May 4th, 2006 Ltd DEVICE DESCRIPTION The Capnostream 20 bedside monitor is a two parameter monitor consisting o…	Oridion Capnography, Inc.	2006	3

Also cleared against K060065: 6 other devices →

What descends from it? (197)

See all 197

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

Number	Device	Applicant	Decided	Descendants
K082268	CAPNOSTREAM20 with Integrated Pulmonary Index	Oridion Capnography, Inc.	2009	170
K083228	Philips Intellivue MP5 Patient Monitor	Philips Medizin Systeme Boblingen GmbH	2008	85
K101619	Welch Allyn 1500 Patient Monitor	Schiller AG	2010	4

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.

K970209Capnocheck PlusBci Intl., Inc. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 11 months on median.
7 of the 35 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K082268 (Oridion Capnography, Inc., 2009) has gone furthest, with 170 descendants of its own.
6 other devices also cite its predicate K060065.

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 Capnostream 20 combined capnograph/pulse oximeter monitor is intended to provide

professionally trained health care providers the continuous, non invasive measurement and

monitoring of carbon dioxide concentration of the expired and inspired breath and

respiration rate, and for the continuous non-invasive monitoring of functional oxygen

saturation of arterial hemoglobin (SpO 2 and pulse rate). It is intended for use with neonatal,

pediatric and adult patients in hospitals, hospital type facilities, intra hospital transport and

home environments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072295 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072295: Capnostream 20 with A2 Adaptive Averaging Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072295

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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