Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Trudell Medical International · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

203 daysmedian FDA review time
281 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242667AeroChamber2go Anti-Static Valved Holding ChamberTrudell Medical International2025-01-151320
K203400Corrugated tube with mouthpiece accessoryTrudell Medical International2021-06-142070
K200063AeroEclipse* ONE BANTrudell Medical International2020-07-171860
K183108Combined Aerobika OPEP and VersaPAP deviceTrudell Medical International2019-08-162810
K181649AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding ChambeTrudell Medical International2019-01-112030
K173918VersaPAP Positive Airway Pressure (PAP) DeviceTrudell Medical International2018-08-172380
K173825MC 300R* NebulizerTrudell Medical International2018-05-021350
K173367MC 300* NebulizerTrudell Medical International2018-02-281250
K150173Aerobika OPEP Devive with ManometerTrudell Medical International2015-10-152620

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