Madavac 190
FDA 510(k) K921611 · Mada Medical Products, Inc.
510(k) numberK921611
Submission
- Device name
- Madavac 190
- Applicant
- Mada Medical Products, Inc.
Carlstadt, NJ, US - Received
- April 3, 1992
- Decision date
- September 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)BTA · Traditional | Shenzhen Desida Technology Co., Ltd. | 05/16/2025SE |
| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 04/23/2025SE |
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|---|---|---|
| K003862 | Mada WheelchairsIOR · Traditional | 01/12/2001SE |
| K002943 | Wheelchair, Mechanical Series Model 3100IOR · Traditional | 10/23/2000SE |
| K950777 | Oxygen RegulatorCAN · Traditional | 04/14/1995SE |
| K930949 | VoyageCAF · Traditional | 06/01/1993SE |
| K930947 | PromenadeCAF · Traditional | 06/01/1993SE |
| K850754 | Medajet XL - Jet InjectorKZE · Traditional | 12/10/1985SE |
| K802426 | RESPO2 Oxygen ConcentratorCAW · Traditional | 10/23/1980SE |
Questions and answers
When was Madavac 190 cleared by the FDA?
Madavac 190 (K921611) received a 510(k) decision of Substantially Equivalent on September 9, 1992, 159 days after the submission was received.
What is the product code of K921611?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.