Trudell Medical International: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Trudell Medical International” (first 2015, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 203 days. Since 2017 the median was 194 days, against 238 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2015 | 1 | 262 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 3 | 135 |
| 2019 | 2 | 242 |
| 2020 | 1 | 186 |
| 2021 | 1 | 207 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 132 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Trudell Medical International took a median 194 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 238 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 4 | 4 |
| BWF | Spirometer, Therapeutic (Incentive) | 3 | 3 |
| NVP | Holding Chambers, Direct Patient Interface | 2 | 2 |
Review panels
- Anesthesiology (9)
Most recent Trudell Medical International 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242667 | AeroChamber2go Anti-Static Valved Holding Chamber | NVP | 2025-01-15 | 132 |
| K203400 | Corrugated tube with mouthpiece accessory | CAF | 2021-06-14 | 207 |
| K200063 | AeroEclipse* ONE BAN | CAF | 2020-07-17 | 186 |
| K183108 | Combined Aerobika OPEP and VersaPAP device | BWF | 2019-08-16 | 281 |
| K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) | NVP | 2019-01-11 | 203 |
| K173918 | VersaPAP Positive Airway Pressure (PAP) Device | BWF | 2018-08-17 | 238 |
| K173825 | MC 300R* Nebulizer | CAF | 2018-05-02 | 135 |
| K173367 | MC 300* Nebulizer | CAF | 2018-02-28 | 125 |
| K150173 | Aerobika OPEP Devive with Manometer | BWF | 2015-10-15 | 262 |
Recalls
openFDA lists no recalls under a recalling firm named Trudell Medical International.
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 Trudell Medical International (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Trudell Medical Intl. (12 510(k)s)
- Trudell Medical (3 510(k)s)
- Trudell Medical Int'L (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trudell Medical International?
FDA lists 9 510(k) clearances under the applicant name “Trudell Medical International” (first 2015, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Trudell Medical International?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trudell Medical International is 203 days. Since 2017: 194 days, versus 238 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Trudell Medical International?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 4); BWF (Spirometer, Therapeutic (Incentive), 3); NVP (Holding Chambers, Direct Patient Interface, 2).
Next steps
- See all 9 Trudell Medical International clearances with predicates and recalls
- Run predicate analysis for product code CAF, Trudell Medical International'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.