510(k) · Cleared

Cleared

Millennia 3500 Series Monitor with Anthesthetic Agent

K974581510(k) TraditionalCleared Oct 28, 1998324-day reviewClass II21 CFR 870.2300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Invivo Research, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Cleared on Oct 28, 1998 as substantially equivalent to K832113 (Datex Division Instrumentarium Corp., 1983) and 6 other predicates after a 324-day review. Its family tree reaches back 1 generation to 1983. 58 later devices descend from it.

Decided: Oct 28, 1998
Review: 324 days
Class: Class II
Product code: DRT
Recalls: None
Predicates: 7

Its longest line of descent runs back 1 generation to K832113 (1983). 7 ancestors in all. 58 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK832113 Normac Anesthetic Agent MonitorDatex Division Instrumentarium Corp. · 1983
This deviceK974581 Millennia 3500 Series Monitor with Anthesthetic AgentInvivo Research, Inc. · 1998
Descendant · cites it directly · 56 of its ownK041918 Integrated Patient Monitoring SystemInvivo Research, Inc. · 2004
Descendant · cites it directly · 56 of its ownK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
Descendant · 2 generations on · 55 of its ownK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
Descendant · 2 generations on · 53 of its ownK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
Descendant · 3 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2004high 6 (2017) · low 0 (2010)2026

Most influential descendants

Showing 5 of 58 · See all

K041918Integrated Patient Monitoring SystemInvivo Research, Inc. · 2004 · cites it directly56descendants
K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004 · cites it directly56descendants
K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005 · 2 generations on55descendants
K0534623160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · 2 generations on53descendants
K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 3 generations on40descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K832113	Normac Anesthetic Agent Monitor	Datex Division Instrumentarium Corp.	1983	—
0 (this device)	K974581	Millennia 3500 Series Monitor with Anthesthetic Agent	Invivo Research, Inc.	1998	—
+1	K041918	Integrated Patient Monitoring System	Invivo Research, Inc.	2004	—
+1	K040915	Magnitude 3150M Mri Patient Monitor, Model 3150M	Invivo Research, Inc.	2004	—
+2	K050399	Mri Compatible Patient Monitoring System, Model 3160	Invivo Research, Inc.	2005	—
+2	K053462	3160 Mri Patient Monitoring System	Invivo Corporation	2006	2
+3	K071641	Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…	Medtronic, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1989	1	0
1991	1	0
1993	2	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	1	0
2006	1	0
2007	2	0
2008	1	0
2009	1	0
2011	2	0
2012	2	0
2013	3	0
2014	3	0
2015	4	0
2016	3	0
2017	6	0
2018	1	0
2019	4	0
2020	4	0
2021	5	0
2022	3	0
2023	6	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K974581, 1983–2026Source: 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.

Planning a device in DRT? 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 DRT device

#1 K252676 The Circadia C300 System (C300)score 15.3 · 6 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? (7)

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
*	K832113	Normac Anesthetic Agent Monitor Summary page 1 …Class IT) Oxygen Gas Analyzer - (73 CBO/21CFR 868.1720 Class II) Predicate Devices: The predicate device(s) are the Datex AS/3 Anesthesia Agent Monitor (510(k) numbers K832113, K903104, K923276, K932098), the Datascope Multinex Anesthetic Agent Monitor (510(k) numbers K883254, K903104), and the Criticare…	Datex Division Instrumentarium Corp.	1983	—
*	K903104	Capnomac Ultima (TM) Anesthesia Monitor Summary page 1 …Oxygen Gas Analyzer - (73 CBO/21CFR 868.1720 Class II) Predicate Devices: The predicate device(s) are the Datex AS/3 Anesthesia Agent Monitor (510(k) numbers K832113, K903104, K923276, K932098), the Datascope Multinex Anesthetic Agent Monitor (510(k) numbers K883254, K903104), and the Criticare Poet II…	Datex Division Instrumentarium Corp.	1991	—
*	K923276	Capnomac Ultima Anesthesia Monitor Summary page 1 …as Analyzer - (73 CBO/21CFR 868.1720 Class II) Predicate Devices: The predicate device(s) are the Datex AS/3 Anesthesia Agent Monitor (510(k) numbers K832113, K903104, K923276, K932098), the Datascope Multinex Anesthetic Agent Monitor (510(k) numbers K883254, K903104), and the Criticare Poet II Anesthesi…	Datex Division Instrumentarium Corp.	1993	—
*	K932098	Capnomac Ultima Anesthesia Monitor Summary page 1 …er - (73 CBO/21CFR 868.1720 Class II) Predicate Devices: The predicate device(s) are the Datex AS/3 Anesthesia Agent Monitor (510(k) numbers K832113, K903104, K923276, K932098), the Datascope Multinex Anesthetic Agent Monitor (510(k) numbers K883254, K903104), and the Criticare Poet II Anesthesia Agent M…	Datex Division Instrumentarium Corp.	1993	—
*	K883254	Multinex Monitor (Modification) Summary page 1 …evice(s) are the Datex AS/3 Anesthesia Agent Monitor (510(k) numbers K832113, K903104, K923276, K932098), the Datascope Multinex Anesthetic Agent Monitor (510(k) numbers K883254, K903104), and the Criticare Poet II Anesthesia Agent Monitor (510(k) numbers K892646, K942737). These predicate devices have the…	Datascope Corp.	1988	—
*	K892646	Biochem 8100 Anesthetic Agent Monitor Summary page 1 …K923276, K932098), the Datascope Multinex Anesthetic Agent Monitor (510(k) numbers K883254, K903104), and the Criticare Poet II Anesthesia Agent Monitor (510(k) numbers K892646, K942737). These predicate devices have the same performance specifications as the Millennia 3500 Series Monitor with Anesthetic…	Biochem International, Inc.	1989	—
*	K942737	Poet IQ with Five Agent Capability Summary page 1 …K932098), the Datascope Multinex Anesthetic Agent Monitor (510(k) numbers K883254, K903104), and the Criticare Poet II Anesthesia Agent Monitor (510(k) numbers K892646, K942737). These predicate devices have the same performance specifications as the Millennia 3500 Series Monitor with Anesthetic Agents Mo…	Criticare Systems, Inc.	1995	—

What descends from it? (58)

See all 58

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

Number	Device	Applicant	Decided	Descendants
K041918	Integrated Patient Monitoring System	Invivo Research, Inc.	2004	56
K040915	Magnitude 3150M Mri Patient Monitor, Model 3150M	Invivo Research, Inc.	2004	56

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?

None of the 7 ancestors has a recall.
Of its descendants, K041918 (Invivo Research, Inc., 2004) has gone furthest, with 56 descendants of its own.

How does its category compare?

All DRT devices

DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRT

1in 2025

2007high 6 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRT

228in 2024

2007high 228 (2024) · low 44 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRT

1in 2024

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRT

40in 2025

2007high 447 (2019) · low 16 (2013)2025

MAUDE reports naming product code DRT, 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	1	—	0	113
2008	1	—	0	99
2009	6	70	0	118
2010	3	44	0	63
2011	3	149	1	36
2012	1	—	0	47
2013	1	—	0	16
2014	0	—	0	26
2015	1	—	0	48
2016	1	—	0	55
2017	1	—	0	159
2018	1	—	0	224
2019	1	—	0	447
2020	0	—	0	50
2021	2	—	1	85
2022	1	—	0	35
2023	1	—	0	47
2024	3	228	1	29
2025	1	—	0	40
2026	5	120	0	—

What is it indicated for?

The Invivo Research Inc. Millennia 3500 Series Monitor with Anesthetic Agent monitoring is intended for general hospital or clinical use by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents monitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide and oxygen gas concentrations. The need to monitor these anesthetic agents is most commonly encountered in the operating room during administration of anesthesia. This device is available for sale only upon the order of a physician or other related licensed medical professional.

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/K974581 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974581: Millennia 3500 Series Monitor with Anthesthetic Agent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974581

Report an extraction error

Are you the manufacturer?

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