# K993282: Ipi Humidifier Chamber

- Pathway: 510(k) (Traditional)
- Applicant: I.P.I. Medical Products
- Decided: Sep 18, 2000 after 354 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: 2 generations back to K850647 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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) Summary page 1.
- K962223: Water Chambers for ST 3000 Heated Humidifier, Marquest Medical Products, Inc. (1997). Our OCR of the scanned summary read K862223, FDA’s number for Micro Thin* Paraffin (Richard-Allan Medical Ind., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Marquest SCT 3000”.
- K864173: HPD Humidifying Chamber, Hpd Medical, Inc. (1987) Summary page 1.
- K850647: Heated Respiratory Humififier MR440, Fisher & Paykel Allied Products, Ltd. (1985) Summary page 1.
- K862923: MR620 Dual Servo Heated Anaesthesia Humidifier, Fisher & Paykel Allied Products, Ltd. (1986) Summary page 1.
- K934140: MR290 Humidification Chamber Single Use, Fisher & Paykel Electronics, Ltd. (1994) Summary page 1.

## Indications for use
The humidifier chambers for the SCT 3000 are indicated for use with the SCT 3000 unit and to hold water required to humidify the air being delivered to patients.

Source page: https://510kreport.com/device/K993282
Methodology: https://510kreport.com/methodology