# K081335: Tenacore Oxygen Blender, Model TB-2000

- Pathway: 510(k) (Traditional)
- Applicant: Tenacore Holdings, Inc.
- Decided: Nov 14, 2008 after 186 days
- Product code: BZR (Mixer, Breathing Gases, Anesthesia Inhalation)
- Device class: 2
- Regulation: 21 CFR 868.5330
- 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 K925982 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925982: BMD Air/Oxygen Blender, Biomedical Devices, Inc. (1993) Summary page 1.

## Most influential descendants
- K113232: Maxmixing Block (2012), 0 descendants of its own

## Indications for use
The Tenacore Oxygen Blender, is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.

Source page: https://510kreport.com/device/K081335
Methodology: https://510kreport.com/methodology