# K253322: Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Mar 25, 2026 after 176 days
- Product code: BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer)
- Device class: 2
- Regulation: 21 CFR 868.5270
- 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 K850647 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151461: Hybernite RT, Plastiflex Group NV (2016) Summary page 5.

## Indications for use
The Hudson RCI® Infant Dri-TechTM Breathing Circuits are intended for neonatal, infant, and pediatric patients weighing 32kg or less in a professional healthcare environment as a conduit for warmed and humidified respiratory gases between a patient and a ventilator and includes heated wires for use with the Hudson RCI Neptune Heated Humidifier.

Source page: https://510kreport.com/device/K253322
Methodology: https://510kreport.com/methodology