# K980551: Silenzio Delta Continuous Positive Airway Pressure System

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Medical Products, Inc.
- Decided: Nov 17, 1998 after 278 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Silenzio Delta is intended for the treatment of Obstructive Sleep Apnea (OSA) in adult patients 30 kg and over. Silenzio Delta has three modes of operation. In CPAP mode,treatment is carried out by applying a continuous positive airway pressure through a nasal mask. In the BPAP mode, the pressure during expiration is lower than during inspiration, as prescribed by the physician. In a third mode, a minimum breathing rate can be set between 0 to 25 BrPM. The operation is identical as in BPAP mode, but if the patient fails to make an inspiratory effort within the interval set by the minimum BrPM control, the device will cycle to the pressure support level to deliver the breath to the patient based on the minimum BrPM setting. The Silenzio Delta can be used to administer oxygen by using external oxygen tank and bleeding oxygen into the patient circuit. This therapy is not metered or otherwise regulated. Patient monitoring must be performed to ensure effective administration of oxygen therapy.

Source page: https://510kreport.com/device/K980551
Methodology: https://510kreport.com/methodology