Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trudell Medical Intl. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
201 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131881 | OMBRA TABLE TOP COMPRESSOR | Trudell Medical Intl. | 2013-10-24 | 121 | 0 |
| K123400 | AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE | Trudell Medical Intl. | 2013-05-16 | 192 | 0 |
| K123614 | SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) | Trudell Medical Intl. | 2013-03-11 | 108 | 0 |
| K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER | Trudell Medical Intl. | 2012-07-11 | 363 | 0 |
| K110136 | RESPICHAMBER VALVED HOLDING CHAMBER | Trudell Medical Intl. | 2011-04-18 | 90 | 0 |
| K090065 | AEROCHAMBER MINI VENTILATION CHAMBER | Trudell Medical Intl. | 2009-04-09 | 90 | 0 |
| K080926 | AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER | Trudell Medical Intl. | 2008-08-12 | 132 | 0 |
| K070674 | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLO | Trudell Medical Intl. | 2007-04-11 | 30 | 0 |
| K053605 | AEROECLIPSE II BREATH ACTUATED NEBULIZER | Trudell Medical Intl. | 2006-02-27 | 62 | 0 |
| K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER | Trudell Medical Intl. | 2005-09-21 | 26 | 0 |
| K032972 | AEROCHAMBER MAX VALVED HOLDING CHAMBER | Trudell Medical Intl. | 2004-01-14 | 112 | 0 |
| K012368 | AEROPEP | Trudell Medical Intl. | 2002-02-12 | 201 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda