# K972798: Dynemo 3000

- Pathway: 510(k) (Traditional)
- Applicant: Sometec, Inc.
- Decided: Feb 24, 1998 after 211 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- 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 K851426 (1985). 3 ancestors in all.
28 later devices descend from it; 4 cite it directly.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884395: HP 21362B Transesophageal Ultrasound Imaging Trans, Hewlett-Packard Co. (1989) Summary page 1.
- K851426: Accucom Cardiac Output Monitor, Lawrence Medical Systems, Inc. (1985) Summary page 1.
- K951369: EDM, Deltex Medical (1995) Summary page 1.

## Most influential descendants
- K021174: Ecom Endotrachial Cardiac Output Monitor (2003), 12 descendants of its own
- K032491: Ecom CV4 Endotracheal Cardiac Output Monitor (2003), 11 descendants of its own
- K094054: Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube (2010), 8 descendants of its own
- K031706: Cardioq, Model 9051-7005 (2003), 7 descendants of its own
- K110989: Neurovision Ink Printed Endotracheal Tube Electrode (2011), 4 descendants of its own

## Indications for use
Non-invasive, continuous, real-time measurement and monitoring of the aortic blood flow for adult patients under anesthesia and/or in intensive care. Derivation of real-time composite hemodynamic profile (aortic blood flow, arterial pressures, heart rate, stroke volume in the aorta, end-tidal CO, pressure, systemic vascular resistances for aortic circuit, systolic time intervals), providing indications of cardiovascular status. Non-invasive, continuous, real-time measurement and monitoring of the aortic blood flow for pediatric patients under anesthesia and/or in intensive care. Derivation of real-time composite hemodynamic profile (aortic blood flow, arterial pressures, heart rate, stroke volume in the aorta, end-tidal CO; pressure, systemic vascular resistances for aortic circuit, systolic time intervals), providing indications of cardiovascular status.

Source page: https://510kreport.com/device/K972798
Methodology: https://510kreport.com/methodology