# K003665: Fadassi Medical FM-1 NO Blender

- Pathway: 510(k) (Traditional)
- Applicant: Fadasis Medical, Inc.
- Decided: Feb 23, 2001 after 87 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
No predicates in its family tree.
28 later devices descend from it; 2 cite it directly.
5 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011874: Fadasis Medical FM-1 NO Blender (2001), 27 descendants of its own
- K052663: Ino Therapeutics Inoblender, Model 10004 (2005), 26 descendants of its own
- K061901: Ino Therapeutics Inomax DS (Delivery System), Model 10003 (2006), 24 descendants of its own
- K092545: Inomax DS (Delivery System), Model 10003 (2010), 16 descendants of its own
- K070867: Inomax DS (Delivery System), Model 10003 (2007), 15 descendants of its own

Source page: https://510kreport.com/device/K003665
Methodology: https://510kreport.com/methodology