Mada Medical Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Mada Medical Products, Inc.” (first 1980, latest 2001), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 75 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| IOR | Wheelchair, Mechanical | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| CAN | Regulator, Pressure, Gas Cylinder | 1 | 1 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| KZE | Injector, Fluid, Non-Electrically Powered | 1 | 1 |
Review panels
Most recent Mada Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003862 | MADA WHEELCHAIRS | IOR | 2001-01-12 | 30 |
| K002943 | WHEELCHAIR, MECHANICAL SERIES MODEL 3100 | IOR | 2000-10-23 | 32 |
| K950777 | OXYGEN REGULATOR | CAN | 1995-04-14 | 52 |
| K930949 | VOYAGE | CAF | 1993-06-01 | 98 |
| K930947 | PROMENADE | CAF | 1993-06-01 | 98 |
| K921611 | MADAVAC 190 | BTA | 1992-09-09 | 159 |
| K850754 | MEDAJET XL - JET INJECTOR | KZE | 1985-12-10 | 288 |
| K802426 | RESPO2 OXYGEN CONCENTRATOR | CAW | 1980-10-23 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Mada Medical Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Mada Medical Products, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Mada Medical Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Mada Medical Products, Inc.” (first 1980, latest 2001), across 6 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mada Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mada Medical Products, Inc. is 75 days.
Which FDA product codes appear under Mada Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 2); IOR (Wheelchair, Mechanical, 2); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Next steps
- See all 8 Mada Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Mada Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.