# K974379: Ultraneb

- Pathway: 510(k) (Traditional)
- Applicant: Bremed Italia, S.R.L.
- Decided: Feb 18, 1998 after 90 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K083256: Ultrasonic Nebulizer System, Model KN-9210 (2009), 0 descendants of its own

## Indications for use
This product is an ultrasonic ncbulizcr that is used to provide acrosolized broncho dialator medication 1o persons with asthma and cmphysema. The device creates acrosolized particles of the prescribed medication via ultrasound that is forced via a vacuum or draw into disposable tubing. The acrosolized medication travels up the tubing and into either a nasal or oral mask. The paticent then inhales the medication as per his/her physician's orders. This product contains the exact same technological characteristics of similar devices currcntly on the market. The product functions cxactly as these similar devices. The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various nasal and oral masks that arc currently in distribution in the United States and Europc. The components found within this product are common items. The product consists of a thermally protccted. simplistic circuit board. a piczcoelectric ceramic. a medicine cup. an ABS plastic casc. a switch. an ¢lectrical cord.

Source page: https://510kreport.com/device/K974379
Methodology: https://510kreport.com/methodology