Dispos. Medication Nebulizer
FDA 510(k) K831270 · Hospitak, Inc.
510(k) numberK831270
Submission
- Device name
- Dispos. Medication Nebulizer
- Applicant
- Hospitak, Inc.
Walker, MI, US - Received
- April 19, 1983
- Decision date
- June 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K955483 | Trach Mask Model (245, 246)BYF · Traditional | 02/28/1996SE |
| K954787 | IlluminatorCCW · Traditional | 01/31/1996SE |
| K953620 | Warm N Wet Hmef W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K953619 | Warm N Wet Hme W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K915750 | Disposable Bacterial Breathng FilterCAH · Traditional | 11/30/1994SE |
| K920842 | Aerosol Delivery SystemsLRD · Traditional | 05/15/1992SE |
| K915228 | Disposable CO2 Gas Sampling/Oxygen Delivery CannulCCK · Traditional | 02/11/1992SE |
| K873286 | Disposable, Manual Pulmonary ResuscitatorBTM · Traditional | 10/26/1987SE |
| K853600 | Inflatable Air SplintsFZF · Traditional | 09/19/1985SE |
| K844328 | Oxygen ConcentratorCAW · Traditional | 12/04/1984SE |
Questions and answers
When was Dispos. Medication Nebulizer cleared by the FDA?
Dispos. Medication Nebulizer (K831270) received a 510(k) decision of Substantially Equivalent on June 8, 1983, 50 days after the submission was received.
What is the product code of K831270?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.