Trudell Medical Intl.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Trudell Medical Intl.” (first 2002, latest 2013), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 110 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 | 1 | 363 |
| 2013 | 3 | 121 |
| 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) | 5 | 5 |
| NVP | Holding Chambers, Direct Patient Interface | 4 | 4 |
| BWF | Spirometer, Therapeutic (Incentive) | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
Review panels
- Anesthesiology (12)
Most recent Trudell Medical Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131881 | OMBRA TABLE TOP COMPRESSOR | BTI | 2013-10-24 | 121 |
| K123400 | AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE | BWF | 2013-05-16 | 192 |
| K123614 | SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) | CAF | 2013-03-11 | 108 |
| K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) | NVP | 2012-07-11 | 363 |
| K110136 | RESPICHAMBER VALVED HOLDING CHAMBER | NVP | 2011-04-18 | 90 |
| K090065 | AEROCHAMBER MINI VENTILATION CHAMBER | CAF | 2009-04-09 | 90 |
| K080926 | AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER | CAF | 2008-08-12 | 132 |
| K070674 | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR | NVP | 2007-04-11 | 30 |
| K053605 | AEROECLIPSE II BREATH ACTUATED NEBULIZER | CAF | 2006-02-27 | 62 |
| K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER | NVP | 2005-09-21 | 26 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Trudell Medical Intl..
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 Intl. (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 International (9 510(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 Intl.?
FDA lists 12 510(k) clearances under the applicant name “Trudell Medical Intl.” (first 2002, latest 2013), across 4 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 Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trudell Medical Intl. is 110 days.
Which FDA product codes appear under Trudell Medical Intl.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 5); NVP (Holding Chambers, Direct Patient Interface, 4); BWF (Spirometer, Therapeutic (Incentive), 2).
Next steps
- See all 12 Trudell Medical Intl. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Trudell Medical Intl.'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.