Medi - Pump
FDA 510(k) K950867 · Thomas Industries
510(k) numberK950867
Submission
- Device name
- Medi - Pump
- Applicant
- Thomas Industries
Sheboygan, WI, US - Received
- February 27, 1995
- Decision date
- April 19, 1995
- 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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|---|---|---|---|
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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 |
|---|---|---|
| K041199 | Medi-Pump Aspirator, Model 1615BTA · Special | 06/01/2004SE |
| K965059 | Cpi, MAXI-VAC(6480),THOMAS Industries, MEDI-PUMP(1240/1242/1243)BTA · Traditional | 03/04/1997SE |
| K952806 | Medi Pump Aspirator Models 1130 and 1135BTA · Traditional | 10/26/1995SE |
| K950290 | Medi - PumpCAF · Traditional | 08/24/1995SE |
| K951729 | Medi - PumpBTA · Traditional | 08/21/1995SE |
| K944399 | Medi-PumpBTA · Traditional | 01/18/1995SE |
| K925010 | Nebulizer Pump, Powered, Model 1110BTI · Traditional | 05/27/1994SE |
| K925011 | Nebulizer Pump, Powered Model 1180BTI · Traditional | 01/12/1994SE |
Questions and answers
When was Medi - Pump cleared by the FDA?
Medi - Pump (K950867) received a 510(k) decision of Substantially Equivalent on April 19, 1995, 51 days after the submission was received.
What is the product code of K950867?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.