# K161718: MaxBlend 2, MaxBlend Lite

- Pathway: 510(k) (Traditional)
- Applicant: Maxtec, LLC
- Decided: Oct 27, 2016 after 127 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). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973646: Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer, Bird Products Corp. (1998) Summary page 4.

## Most influential descendants
- K243917: F&P Optiflow Air/Oxygen Flow Source (2025), 0 descendants of its own
- K231895: Maxtec MaxBlend2+p (2023), 0 descendants of its own

## Indications for use
The MaxBlend 2 and MaxBlend Lite are designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e., hospital, sub-acute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life supporting device.

Source page: https://510kreport.com/device/K161718
Methodology: https://510kreport.com/methodology