# K142153: Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15ML

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Apr 29, 2015 after 266 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K870332 (1987). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113033: Sodium Chlorde Inhalation Solution, 0.9% Usp-3ML, Nephron Pharmaceuticals Corp. (2012) Summary page 5.
- (no number) Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution: named in the summary without a submission number

## Most influential descendants
- K231058: Hudson RCI® AddiPak® Unit Dose Vial (2024), 0 descendants of its own

## Recalls of this device
- Aug 4, 2023 · Class I · Z-2514-2023: Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.

## Indications for use
The Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution may be used in conjunction with a non-ventilatory nebulizer for lavage therapy, or for tracheal irrigation.

Source page: https://510kreport.com/device/K142153
Methodology: https://510kreport.com/methodology