Apex Medical Minineb & Miniplus
FDA 510(k) K050104 · Apex Medical Corp.
510(k) numberK050104
Submission
- Device name
- Apex Medical Minineb & Miniplus
- Applicant
- Apex Medical Corp.
Tucheng City, Taipei County, TW - Received
- January 18, 2005
- Decision date
- February 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K213577 | VenAir, Sequential Compression SystemJOW · Traditional | 06/28/2022SE |
| K193206 | WiZARD 510 Nasal MaskBZD · Traditional | 10/29/2020SE |
| K182394 | WiZARD 310/320 Series CPAP MaskBZD · Traditional | 05/17/2019SE |
| K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesBZD · Traditional | 09/15/2015SE |
| K141522 | Apex Medical Corp. Ich CPAP with Pva 9S-007XXX SeriesBZD · Traditional | 10/06/2014SE |
| K121642 | Wizard 230 Nasal Pilow MaskBZD · Traditional | 06/06/2013SE |
| K112079 | Apex Medical XT Auto CPAP with Compliance Improvement Algorithm 9S-005720BZD · Traditional | 12/06/2012SE |
| K120035 | Apex Medical Ich CPAP Series (9S-007XXX)BZD · Special | 05/16/2012SE |
| K103174 | Apex Medical Wizard Series CPAP MaskBZD · Traditional | 05/06/2011SE |
| K103535 | Vacplus Suction UnitJCX · Traditional | 02/24/2011SE |
Questions and answers
When was Apex Medical Minineb & Miniplus cleared by the FDA?
Apex Medical Minineb & Miniplus (K050104) received a 510(k) decision of Substantially Equivalent on February 16, 2005, 29 days after the submission was received.
What is the product code of K050104?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.