Thera-Mist(Tm) Nebulizer, Model 30000
FDA 510(k) K893942 · Pegasus Research Corp.
510(k) numberK893942
Submission
- Device name
- Thera-Mist(Tm) Nebulizer, Model 30000
- Applicant
- Pegasus Research Corp.
Costa Mesa, CA, US - Received
- May 31, 1989
- Decision date
- August 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| K251572 | eRapid with eTrack SystemCAF · Traditional | Pari Respiratory Equipment, Inc. | 12/19/2025SE |
| K251659 | Mesh Nebulizer (H6)CAF · Traditional | Qingdao Future Medical Technology Co., Ltd. | 11/14/2025SE |
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| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer…CAF · Traditional | Joytech Healthcare Co. , Ltd. | 07/02/2025SE |
| K250022 | HeroTracker SenseCAF · Traditional | Voluntis | 06/30/2025SE |
| K250583 | AdheResp Smart Breath-actuated Mesh NebulizerCAF · Traditional | Hcmed Innovations Co., Ltd. | 06/20/2025SE |
| K242354 | AllNEBCAF · Traditional | Enchant Tek Co. , Ltd. | 04/29/2025SE |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | Thayer Medical Corporation | 06/18/2024SE |
| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
More from Aerogen, Ltd.
| 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 |
| K894000 | Thera-Mist HumidifierBTT · Traditional | 08/28/1989SE |
Questions and answers
When was Thera-Mist(Tm) Nebulizer, Model 30000 cleared by the FDA?
Thera-Mist(Tm) Nebulizer, Model 30000 (K893942) received a 510(k) decision of Substantially Equivalent on August 28, 1989, 89 days after the submission was received.
What is the product code of K893942?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.