# K960854: Siemens Servo Ultra Nebulizer 345

- Pathway: 510(k) (Traditional)
- Applicant: Pacesetter, Inc.
- Decided: Dec 23, 1996 after 297 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.
4 later devices descend from it; 3 cite it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Microsonic Ultrasonic Nebulizer: named in the summary without a submission number
- (no number) Omron NE-UO7 Ultra-Air: named in the summary without a submission number
- (no number) Siemens Servo Nebulizer 945: named in the summary without a submission number

## Most influential descendants
- K990897: Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb Nebulizer (2000), 2 descendants of its own
- K041082: Newport Nebsonic N550 Ultrasonic Nebulizer (2004), 0 descendants of its own
- K020357: 800 Series Easyneb Nebulizer (2002), 0 descendants of its own
- K021175: Aeroneb Professional Nebulizer System, Model#AG-AP6000 (2002), 0 descendants of its own

## Indications for use
The intended use of the Siemens Model 345 Ultra Nebulizer is to nebulize liquid medication for introduction into the patient’s airway via an endotracheal tube. It can be used on any patient for whom the use of the Siemens Servo Ventilator 300 is indicated, in any ventilatory mode appropriate for the patient.

Source page: https://510kreport.com/device/K960854
Methodology: https://510kreport.com/methodology