510(k) · Cleared

Cleared

Microcap Plus/NPB-75

K024300510(k) SpecialCleared Apr 3, 2003100-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 Medical 1987, Ltd. · DQA Oximeter

Cleared on Apr 3, 2003 as substantially equivalent to K964239 (Spegas Industries, Ltd., 1997) after a 100-day review. Its family tree reaches back 2 generations to 1995. 20 later devices descend from it.

Decided: Apr 3, 2003
Review: 100 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K950387 (1995). 20 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK950387 GeminiSpegas Industries, Ltd. · 1995
1 generation backK964239 Combination Oximeter/Carbon Dioxide Gas AnalyzerSpegas Industries, Ltd. · 1997
This deviceK024300 Microcap Plus/NPB-75Oridion Medical 1987, Ltd. · 2003
Descendant · cites it directly · 12 of its ownK063752 Lifesense, Model LS1-9RNonin Medical, Inc. · 2007
Descendant · 2 generations on · 7 of its ownK092101 Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009
Descendant · cites it directly · 4 of its ownK040246 Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc. · 2004
Descendant · 3 generations on · 3 of its ownK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
Descendant · 2 generations on · 3 of its ownK081891 Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2004high 3 (2009) · low 0 (2005)2026

Most influential descendants

Showing 5 of 20 · See all

K063752Lifesense, Model LS1-9RNonin Medical, Inc. · 2007 · cites it directly12descendants
K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009 · 2 generations on7descendants
K040246Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc. · 2004 · cites it directly4descendants
K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · 3 generations on3descendants
K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K950387	Gemini	Spegas Industries, Ltd.	1995	—
−1	K964239	Combination Oximeter/Carbon Dioxide Gas Analyzer	Spegas Industries, Ltd.	1997	—
0 (this device)	K024300	Microcap Plus/NPB-75	Oridion Medical 1987, Ltd.	2003	—
+1	K063752	Lifesense, Model LS1-9R	Nonin Medical, Inc.	2007	—
+2	K092101	Reusable Pulse Oximeter Sensor, Model 8000 Series	Nonin Medical, Inc.	2009	—
+1	K040246	Fukuda Denshi Dynascope Model DS-7141 Portable Patient Monitor	Fukuda Denshi USA, Inc.	2004	—
+3	K132402	Sensmart Model X-100 Univeral Oximetry System	Nonin Medical, Inc.	2014	1
+2	K081891	Fukuda Denshi Dynascope Model DS-7000/7000M Patient Monitor	Fukuda Denshi USA, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0
2008	1	0
2009	3	0
2010	2	0
2011	2	0
2014	1	0
2015	2	0
2016	1	0
2018	1	0
2019	1	0
2020	1	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K024300, 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.

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
*	K964239	Combination Oximeter/Carbon Dioxide Gas Analyzer Summary page 1 …: +972-2-586-6680 DEVICE LISTING FDA FORM 2892: BO51971 DEVICE DESCRlPTlON The Oridion MicroCap Plus/NPB-75 (the device being modified) (K964239) is an integrated instrument that measures end tidal C02 (EtC02) and saturated arterial oxygen (Sp02). As a derivativ…	Spegas Industries, Ltd.	1997	—

Also cleared against K964239: 6 other devices →

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K063752	Lifesense, Model LS1-9R	Nonin Medical, Inc.	2007	12
K040246	Fukuda Denshi Dynascope Model DS-7141 Portable Patient Monitor	Fukuda Denshi USA, Inc.	2004	4
K083056	Neo-Stat CO2 <KG	Mercury Medical	2009	1

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?

The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K063752 (Nonin Medical, Inc., 2007) has gone furthest, with 12 descendants of its own.
6 other devices also cite its predicate K964239.

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 MicroCap Plus /NPB-75 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 of arterial oxygen saturation (SpOn) and pulse rate.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024300 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024300: Microcap Plus/NPB-75.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024300

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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