Pharmacaribe Inhaled Saline Solutions
FDA 510(k) K101424 · Pharmacaribe
510(k) numberK101424
Submission
- Device name
- Pharmacaribe Inhaled Saline Solutions
- Applicant
- Pharmacaribe
Bonita Springs, FL, US - Received
- May 20, 2010
- Decision date
- August 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
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Questions and answers
When was Pharmacaribe Inhaled Saline Solutions cleared by the FDA?
Pharmacaribe Inhaled Saline Solutions (K101424) received a 510(k) decision of Substantially Equivalent on August 17, 2010, 89 days after the submission was received.
What is the product code of K101424?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.