Pari Baby
FDA 510(k) K944152 · Pari Holding Co.
510(k) numberK944152
Submission
- Device name
- Pari Baby
- Applicant
- Pari Holding Co.
Richmond, VA, US - Received
- August 22, 1994
- Decision date
- November 18, 1994
- 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 |
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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 |
|---|---|---|
| K002862 | Proneb Ultra Model Number 85B0100BTI · Traditional | 03/13/2001SE |
| K983308 | RC Cornet, Model #44F50BWF · Traditional | 06/04/1999SE |
| K972042 | Pari Pep Therapy SystemBWF · Traditional | 08/05/1997SE |
| K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70CAF · Traditional | 12/10/1996SE |
| K962072 | Proneb Turbo Compressor Model 38V0200CAF · Traditional | 08/21/1996SE |
| K960675 | Walkhaler Portable Compressor Model 45F70CAF · Traditional | 05/17/1996SE |
| K935540 | Pari-Master ModificationCAF · Traditional | 03/17/1995SE |
Questions and answers
When was Pari Baby cleared by the FDA?
Pari Baby (K944152) received a 510(k) decision of Substantially Equivalent on November 18, 1994, 88 days after the submission was received.
What is the product code of K944152?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.