# K231895: Maxtec MaxBlend2+p

- Pathway: 510(k) (Traditional)
- Applicant: Maxtec, LLC
- Decided: Dec 4, 2023 after 159 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: 4 generations back to K911344 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161718: MaxBlend 2, MaxBlend Lite, Maxtec, LLC (2016) Summary page 5.
- K221734: Maxtec MaxO2 ME+p, Maxtec, LLC (2023) Summary page 5.

## Indications for use
The Maxtec MaxBlend 2+p is intended to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen and pressure 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, subacute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life-supporting device or life sustaining device.

Source page: https://510kreport.com/device/K231895
Methodology: https://510kreport.com/methodology