# K080230: Neb-U-Mask System, Models 1895, 1896

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Jun 9, 2008 after 131 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
Longest line of descent: 2 generations back to K980407 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980407: Hope Nebulizer, B&B Medical Technologies, Inc. (1998) Summary page 1.
- K040718: TRUST, Dhd Healthcare Corp. (2004) Summary page 1.
- K930525: Micro Mist (TM) Nebulizer, Hudson Respiratory Care, Inc. (1993) Summary page 1.

## Most influential descendants
- K130379: Rollins 7 Oxygen Mask (2013), 0 descendants of its own

## Indications for use
For the delivery of high concentrations of oxygen or Heliox gas mixtures in combination with aerosolized medications and diagnostic formulations. This device has not been tested for use with Pentamidine or the combination of Heliox and metered dose inhaler.

Source page: https://510kreport.com/device/K080230
Methodology: https://510kreport.com/methodology