# K113232: Maxmixing Block

- Pathway: 510(k) (Traditional)
- Applicant: Maxtec, Inc.
- Decided: Mar 1, 2012 after 120 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: 2 generations back to K883038 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884973: FR6000 Flowmeter, Key Instruments (1989) Summary page 1.
- K053232: Precision Blender, Precision Medical, Inc. (2006) Summary page 1.
- K081335: Tenacore Oxygen Blender, Model TB-2000, Tenacore Holdings, Inc. (2008) Summary page 1.
- K973646: Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer, Bird Products Corp. (1998) Summary page 1.

## Indications for use
The MaxMixing Block, a breathing gas mixer designed to provide intermittent or continuous controlled flows of an air/oxygen gas mixture to infant, pediatric, and adult patients. The MaxMixing Block is intended to be used with a Maxtec Oxygen Analyzer. The MaxMixing Block is a restricted medical device intended for use by qualified trained personnel under the direction of a physician in institutional environments where delivery and monitoring of air/oxygen mixtures is required.

Source page: https://510kreport.com/device/K113232
Methodology: https://510kreport.com/methodology