# K000186: Datex-Ohmeda Inovent Delivery System

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda
- Decided: Feb 10, 2000 after 27 days
- Product code: MRN (Apparatus, Nitric Oxide Delivery)
- Device class: 2
- Regulation: 21 CFR 868.5165
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 1 cites it directly.
5 of 26 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
- 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
- K071516: Inomax DS (2007), 14 descendants of its own
- K093922: Inomax DS (2010), 11 descendants of its own

## Recalls of this device
- Jun 29, 2006 · Not classified · Z-1410-06: The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.

Source page: https://510kreport.com/device/K000186
Methodology: https://510kreport.com/methodology