Microflow
FDA 510(k) K924684 · Mountain Medical Equipment, Inc.
510(k) numberK924684
Submission
- Device name
- Microflow
- Applicant
- Mountain Medical Equipment, Inc.
Littleton, CO, US - Received
- September 16, 1992
- Decision date
- December 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K244035 | Portable mesh nebulizer (JM821)CAF · Traditional | Shenzhen Jermei Medical Device Technology Co.… | 09/19/2025SE |
| 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 |
|---|---|---|
| K941793 | Oxygen Concentration Status Indicator (O.C.S.I.)CCL · Traditional | 06/21/1995SE |
| K923650 | ScottyCAW · Traditional | 01/15/1993SE |
| K914916 | Alpine VCAW · Traditional | 09/23/1992SE |
| K902890 | Aspen 3 Oxygen ConcentratorCAW · Traditional | 07/19/1990SE |
| K893531 | Cuff SpeculumKPL · Traditional | 06/22/1989SE |
| K884084 | Portable Oxygen GeneratorCAW · Traditional | 11/21/1988SE |
| K881802 | Alpine Portable Oxygen GeneratorCAW · Traditional | 07/08/1988SE |
| K873677 | Econo-Mist Portable Compressor Driven NebulizerBTI · Traditional | 10/20/1987SE |
| K873170 | AriesBYE · Traditional | 09/25/1987SE |
| K864005 | AlpineCAW · Traditional | 01/28/1987SE |
Questions and answers
When was Microflow cleared by the FDA?
Microflow (K924684) received a 510(k) decision of Substantially Equivalent on December 15, 1992, 90 days after the submission was received.
What is the product code of K924684?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.