# K132892: Tebco-W

- Pathway: 510(k) (Traditional)
- Applicant: Bomed, Inc.
- Decided: Aug 1, 2014 after 319 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- 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 K962128 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962128: Tebco (Thoracic Electrical Bioimpedance Cardiac Output), Hemo Sapiens, Inc. (1996) Summary page 5.

## Indications for use
Adults, Hospital, Cardiology, Internal medicine TEBCO-W is indicated for noninvasive, continuous assessment and monitoring of the left-ventricular performance and global blood flow (Stroke Index, SI and Cardiac Index, CI) in adults, where use of invasive catheters is contraindicated. The device may be used only on the order of a physician and is ”By prescription only.” The intended use is physician’s office and cardiovascular physiology laboratory.

Source page: https://510kreport.com/device/K132892
Methodology: https://510kreport.com/methodology