# K072136: Ultrasonic Nebuliser Model 2010

- Pathway: 510(k) (Traditional)
- Applicant: Wilfred Kromker GmbH
- Decided: Jul 15, 2008 after 348 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: 1 generation back to K872826 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872826: Ultra-Neb 99 Ultrasonic Nebulizer, The Devilbiss Co. (1987) Summary page 1.

## Indications for use
The Kr6mker Medizintechnik Nebulizer Model Ultra-Neb 2010 is designed to aerosolize saline solution and liquid medication by ultrasonic energy. A single patient use medication cup is available for use with medications. The device is intended for use on adult and pediatric patients who have been prescribed inhalation therapy, sputum induction, or medication for nebulization. The device is intended for use in hospitals, hospital-type facilities, nursing home, sub-acute institutions, and home environments. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K072136
Methodology: https://510kreport.com/methodology