Remrest Heated Humidifier
FDA 510(k) K050990 · Medical Industries America, Inc.
510(k) numberK050990
Submission
- Device name
- Remrest Heated Humidifier
- Applicant
- Medical Industries America, Inc.
Adel, IA, US - Received
- April 19, 2005
- Decision date
- May 2, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
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| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special | Fisher & Paykel Healthcare, Ltd. | 06/25/2025SE |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/30/2025SE |
| K241778 | Hudson RCI Comfort Flo® CubCannulaBTT · Traditional | Medline Industries, LP | 12/19/2024SE |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
More from Medline Industries, LP
| 510(k) | Device | Decision |
|---|---|---|
| K032170 | Transneb Compressor W/Nebulizer, Model 5000CAF · Traditional | 05/28/2004SE |
| K002763 | RemrestBZD · Traditional | 05/04/2001SE |
| K011053 | OptimaITI · Traditional | 04/20/2001SE |
| K964078 | 3050 Sport-NebCAF · Traditional | 01/10/1997SE |
| K943990 | 3000 Aerosol TwoCAF · Traditional | 03/21/1995SE |
| K942444 | 3002 AeromaxCAF · Traditional | 03/10/1995SE |
| K941961 | 605 Vacu-MaxBTA · Traditional | 03/02/1995SE |
| K942208 | 4003 AeroliteCAF · Traditional | 02/24/1995SE |
| K940630 | 503 Maxi CompressorBTI · Traditional | 02/21/1995SE |
| K905593 | SleepapBZD · Traditional | 04/23/1991SE |
Questions and answers
When was Remrest Heated Humidifier cleared by the FDA?
Remrest Heated Humidifier (K050990) received a 510(k) decision of Substantially Equivalent on May 2, 2005, 13 days after the submission was received.
What is the product code of K050990?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.