Mini Heart
FDA 510(k) K923690 · B&B Medical Technologies, Inc.
510(k) numberK923690
Submission
- Device name
- Mini Heart
- Applicant
- B&B Medical Technologies, Inc.
Rancho Cordova, CA, US - Received
- July 24, 1992
- Decision date
- October 20, 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
Other 510(k)s with product code CAF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)CAF · Traditional | FindAir Sp. z o.o. | 06/02/2026SE |
| 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 |
|---|---|---|
| K030396 | Omni~Neb; Omni~MaxCAF · Traditional | 05/07/2004SE |
| K980407 | Hope NebulizerCAF · Traditional | 05/27/1998SE |
| K960663 | Universal Bite BlockJXL · Traditional | 05/17/1996SE |
| K945816 | Quick-LockBTR · Traditional | 01/13/1995SE |
| K944324 | Sure-Lock Ventilator Tubing HolderBTR · Traditional | 11/04/1994SE |
| K935171 | StabiltrachCBH · Traditional | 12/02/1993SE |
| K925386 | Adhesive E.T. TapeCBH · Traditional | 04/19/1993SESK |
| K913015 | Heart Nebulizer Flowmeter AdaptorCAF · Traditional | 11/20/1991SE |
| K913753 | Bodai NEO2 -Safe Airway Pressure CapCAI · Traditional | 10/23/1991SE |
| K913000 | Heart Nebulizer Pole ClampCAF · Traditional | 08/02/1991SE |
Questions and answers
When was Mini Heart cleared by the FDA?
Mini Heart (K923690) received a 510(k) decision of Substantially Equivalent on October 20, 1992, 88 days after the submission was received.
What is the product code of K923690?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.