# K970478: SCT 3000 Heated Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Marquest Medical Products, Inc.
- Decided: Jul 16, 1997 after 159 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
Longest line of descent: 1 generation back to K903138 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903138: Marquest SCT 3000, Heated Humidification System, Marquest Medical Products, Inc. (1990). Our OCR of the scanned summary read K503138, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Marquest SCT 3000”.
- K913368: Models MR700/MR720/MR730 Dual Servo Resp Humid Acc, Fisher & Paykel Electronics, Ltd. (1992) Summary page 1.

## Indications for use
The SCT 3000 Heated Humidifier is indicated for use with breathing circuits when healthcare professionals require humidified and /or heated gas being delivered to patients.

Source page: https://510kreport.com/device/K970478
Methodology: https://510kreport.com/methodology