# K974581: Millennia 3500 Series Monitor with Anthesthetic Agent

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Research, Inc.
- Decided: Oct 28, 1998 after 324 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K832113 (1983). 7 ancestors in all.
58 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832113: Normac Anesthetic Agent Monitor, Datex Division Instrumentarium Corp. (1983) Summary page 1.
- K903104: Capnomac Ultima (TM) Anesthesia Monitor, Datex Division Instrumentarium Corp. (1991) Summary page 1.
- K923276: Capnomac Ultima Anesthesia Monitor, Datex Division Instrumentarium Corp. (1993) Summary page 1.
- K932098: Capnomac  Ultima Anesthesia Monitor, Datex Division Instrumentarium Corp. (1993) Summary page 1.
- K883254: Multinex Monitor (Modification), Datascope Corp. (1988) Summary page 1.
- K892646: Biochem 8100 Anesthetic Agent Monitor, Biochem International, Inc. (1989) Summary page 1.
- K942737: Poet IQ with Five  Agent Capability, Criticare Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K041918: Integrated Patient Monitoring System (2004), 56 descendants of its own
- K040915: Magnitude 3150M Mri Patient Monitor, Model 3150M (2004), 56 descendants of its own
- K050399: Mri Compatible Patient Monitoring System, Model 3160 (2005), 55 descendants of its own
- K053462: 3160 Mri Patient Monitoring System (2006), 53 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K974581
Methodology: https://510kreport.com/methodology