510(k) · Cleared

Cleared

Sat-2 Oximeter/Cardiac Output Computer

K884329510(k) TraditionalCleared Dec 16, 198863-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 Dec 16, 1988 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 68 later devices descend from it.

Decided: Dec 16, 1988
Review: 63 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 0

68 later devices descend from it, 1 citing it directly.

This deviceK884329 Sat-2 Oximeter/Cardiac Output ComputerBaxter Healthcare Corp · 1988
Descendant · cites it directly · 67 of its ownK960614 Somanetics Invos 3100A Cerebral Oximeter (Invos)Somanetics Corp. · 1996
Descendant · 2 generations on · 63 of its ownK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
Descendant · 2 generations on · 59 of its ownK073036 Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008
Descendant · 2 generations on · 59 of its ownK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
Descendant · 2 generations on · 58 of its ownK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

1996high 8 (2023) · low 0 (1998)2026

Most influential descendants

Showing 5 of 68 · See all

K960614Somanetics Invos 3100A Cerebral Oximeter (Invos)Somanetics Corp. · 1996 · cites it directly67descendants
K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005 · 2 generations on63descendants
K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008 · 2 generations on59descendants
K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006 · 2 generations on59descendants
K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009 · 2 generations on58descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K884329	Sat-2 Oximeter/Cardiac Output Computer	Baxter Healthcare Corp	1988	—
+1	K960614	Somanetics Invos 3100A Cerebral Oximeter (Invos)	Somanetics Corp.	1996	—
+2	K051257	Adult Cerebral Oximeter, Model 2040	Cas Medical Systems, Inc.	2005	—
+2	K073036	Fore-Sight, MC-2000 Series	Cas Medical Systems, Inc.	2008	—
+2	K061960	Fore-Sight Cerebral Oximeter Monitor, Model 2040	Cas Medical Systems, Inc.	2006	—
+2	K083892	Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)	Cas Medical Systems, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
2005	1	0
2006	1	0
2008	2	0
2009	2	0
2010	4	0
2011	1	0
2012	2	0
2013	1	0
2014	2	0
2015	3	0
2016	2	0
2017	1	0
2018	1	0
2019	4	0
2020	3	0
2021	7	0
2022	6	0
2023	8	0
2024	6	0
2025	6	0
2026	3	0

FIG. 1 — Lineage of K884329, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (68)

See all 68

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

Number	Device	Applicant	Decided	Descendants
K960614	Somanetics Invos 3100A Cerebral Oximeter (Invos)	Somanetics Corp.	1996	67

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?

Of its descendants, K960614 (Somanetics Corp., 1996) has gone furthest, with 67 descendants of its own.

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	—

https://510kreport.com/device/K884329 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884329: Sat-2 Oximeter/Cardiac Output Computer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884329

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026