Aerosol Masks, 81426, 81476, 81490 & 81492
FDA 510(k) K913220 · Specialty Packaging Producs, Inc.
510(k) numberK913220
Submission
- Device name
- Aerosol Masks, 81426, 81476, 81490 & 81492
- Applicant
- Specialty Packaging Producs, Inc.
El Paso, TX, US - Received
- July 19, 1991
- Decision date
- October 10, 1991
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K922492 | Specialty Packaging Prod Bacterial/Viral FilterCAH · Traditional | 08/24/1992SE |
| K913163 | Non Rebreathing ValveCBP · Traditional | 02/03/1992SE |
| K913422 | Oxygen Tubing, 81503BYX · Traditional | 01/30/1992SE |
| K913216 | Trach T AdapterBZA · Traditional | 01/15/1992SE |
| K913164 | Non Rebreathing MaskKGB · Traditional | 01/15/1992SE |
| K913421 | Nasal Oxygen Cannula, 81585, 81587 & 81589CAT · Traditional | 10/18/1991SE |
| K913383 | Oxygen Masks 81420, 81421, 81471 & 81461BYG · Traditional | 10/18/1991SE |
| K913275 | Venturi Oxygen MaskBYG · Traditional | 10/10/1991SE |
| K913455 | Oxygen Masks 82400 & 82405BYG · Traditional | 10/02/1991SE |
| K910896 | Disposable Anesthesia Breathing CircuitCAI · Traditional | 05/08/1991SE |
Questions and answers
When was Aerosol Masks, 81426, 81476, 81490 & 81492 cleared by the FDA?
Aerosol Masks, 81426, 81476, 81490 & 81492 (K913220) received a 510(k) decision of Substantially Equivalent on October 10, 1991, 83 days after the submission was received.
What is the product code of K913220?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.