# K122689: Inoblender

- Pathway: 510(k) (Special)
- Applicant: Ino Therapeutics
- Decided: Nov 7, 2012 after 64 days
- Product code: MRO (Apparatus, Nitric Oxide, Backup Delivery)
- Device class: 2
- Regulation: 21 CFR 868.5165
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003665 (2001). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
5 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052663: Ino Therapeutics Inoblender, Model 10004, Ino Therapeutics (2005) Summary page 1.

## Most influential descendants
- K171696: NOxBOXi Nitric Oxide Delivery System (2018), 4 descendants of its own
- K201339: The NOxBOXi Nitric Oxide Delivery System (2020), 3 descendants of its own
- K220898: NOxBOXi Nitric Oxide Delivery System (2022), 2 descendants of its own
- K231823: NOxBOXi Nitric Oxide Delivery System (2023), 1 descendant of its own
- K233251: NOxBOXi Nitric Oxide Delivery System (2024), 0 descendants of its own

## Indications for use
The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the INOblender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The INOblender is not intended for use as a primary NO delivery system for long-term use.

Source page: https://510kreport.com/device/K122689
Methodology: https://510kreport.com/methodology