Thera-Mist Humidifier
FDA 510(k) K894000 · Pegasus Research Corp.
510(k) numberK894000
Submission
- Device name
- Thera-Mist Humidifier
- Applicant
- Pegasus Research Corp.
Costa Mesa, CA, US - Received
- June 5, 1989
- Decision date
- August 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
Other 510(k)s with product code BTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262268 | Optiflow Oxygen Kit (AA484J)BTT · Special | Fisher and Paykel Healthcare Limited | 08/27/2026SE |
| K254078 | HVT 2.0BTT · Traditional | Vapotherm, Inc. | 04/13/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | Flexicare Medical Limited. | 01/16/2026SE |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/14/2026SE |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special | Fisher & Paykel Healthcare, Ltd. | 12/19/2025SE |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | Medline Industries, LP | 07/02/2025SE |
| 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 |
|---|---|---|
| K122857 | Hope Continuous Nebulizer Model HOPE-11310, Heart Nebulizer Model HEART-100609…CAF · Traditional | 11/07/2012SE |
| K020700 | PMH 5000 Heated Humidifier for Respiratory TherapyBTT · Traditional | 04/26/2004SE |
| K013856 | PMH 1000 Heated HumidifierBTT · Traditional | 02/21/2003SE |
| K983783 | Heated HumidifierBTT · Traditional | 10/24/2000SE |
| K962534 | Thera-Mist Nebulizer MODEL-P3000CAF · Traditional | 02/28/1997SE |
| K946057 | Aqualarm Moisture Sensor Model P85000BYH · Traditional | 05/05/1995SE |
| K915890 | Autoclavable Thera-Mist Humidifier P3600, ModifiedBTT · Traditional | 06/24/1992SE |
| K914465 | Autoclavable Version Thera-Mist Nebulizer, P32000CAF · Traditional | 03/31/1992SE |
| K903489 | Thera-Mist TM Volumina Incent Spirometer, P40000BWF · Traditional | 12/10/1990SE |
| K893942 | Thera-Mist(Tm) Nebulizer, Model 30000CAF · Traditional | 08/28/1989SE |
Questions and answers
When was Thera-Mist Humidifier cleared by the FDA?
Thera-Mist Humidifier (K894000) received a 510(k) decision of Substantially Equivalent on August 28, 1989, 84 days after the submission was received.
What is the product code of K894000?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.