Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

PNZ — Predicate Candidate Screening

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

147 daysmedian FDA review time
284 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.2026-02-19930
K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.2023-12-132710
K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH2023-08-032510
K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon DilFiagon GmbH2023-05-261370
K220027Audion ET dilation systemEntellus Medical, Inc.2022-04-12970
K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.2021-08-161470
K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.2018-01-162160
K163509XprESS ENT Dilation SystemEntellus Medical, Inc.2017-04-051110
DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemAcclarent, Inc.2016-09-162840

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