Cadema Medical Products, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cadema Medical Products, Inc.” (first 1985, latest 1990), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 58 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 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| BYG | Mask, Oxygen | 1 | 1 |
| IYT | System, Rebreathing, Radionuclide | 1 | 1 |
Review panels
- Anesthesiology (3)
- General Hospital (2)
- Radiology (1)
Most recent Cadema Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K901476 | MODIFIED ENTRAPPING FILTER | CAH | 1990-05-01 | 41 |
| K896773 | DISPOSABLE FACE MASK | BYG | 1990-01-12 | 42 |
| K896116 | ENTRAPPING FILTER | CAH | 1989-11-17 | 28 |
| K881812 | AERO-MIST NEBULIZER | IYT | 1988-07-18 | 81 |
| K873930 | AEROSOL DELIVERY SYSTEM (AERO-TECH II) | CAF | 1987-12-07 | 73 |
| K800023 | LUNG AEROSOL UNIT | CAF | 1985-01-01 | 1821 |
Recalls
openFDA lists no recalls under a recalling firm named Cadema 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 Cadema Medical Products, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Cadema Medical Products, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Cadema Medical Products, Inc.” (first 1985, latest 1990), across 4 product codes in 3 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 Cadema Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cadema Medical Products, Inc. is 58 days.
Which FDA product codes appear under Cadema Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 2); CAH (Filter, Bacterial, Breathing-Circuit, 2); BYG (Mask, Oxygen, 1).
Next steps
- See all 6 Cadema Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Cadema 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.