# K923559: Steri-Cath Mdi

- Pathway: 510(k) (Traditional)
- Applicant: Concord/Portex
- Decided: Oct 25, 1993 after 465 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 2 cite it directly.
2 of 24 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
- K030570: Blue Line Ultra Suctionaid Tracheostomy Tube (2003), 21 descendants of its own
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (2004), 12 descendants of its own
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own
- K073383: Well Lead Reinforced Endotracheal Tube (2008), 5 descendants of its own
- K173384: BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube (2018), 4 descendants of its own

Source page: https://510kreport.com/device/K923559
Methodology: https://510kreport.com/methodology