# K983862: Cloud 1 Humidification System

- Pathway: 510(k) (Traditional)
- Applicant: Respiratory Support Products, Inc.
- Decided: May 24, 1999 after 203 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- 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. The FDA summary names its predicate without a number.
- (no number) Intertech/Inspiron Vapor Phase Model 009500 "Advanced" Humidifier: named in the summary without a submission number
- (no number) Intertech/Inspiron Vapor Phase Model 009300 "Plus" Humidifier: named in the summary without a submission number
- (no number) Intertech/Inspiron Vapor Phase Model 009900 Heated Wire Controller: named in the summary without a submission number
- (no number) Fisher Paykell Model MR630 Humidifier: named in the summary without a submission number
- (no number) Marquest Model SCT 3000 Humidifier: named in the summary without a submission number
- (no number) RCI Model 380-88: named in the summary without a submission number

## Indications for use
The Cloud 1 Humidification System is intended to warm and humidify gas before it is delivered to the airway of a patient requiring mechanical ventilation or ventilatory assistance.

Source page: https://510kreport.com/device/K983862
Methodology: https://510kreport.com/methodology