Atlas FDA

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

Arobella Medical, LLC · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K131096AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEMArobella Medical, LLC2014-05-163930
K091038AS 1000 ULTRASOUND WOUND THERAPY SYSTEMArobella Medical, LLC2009-06-19670
K062544AR1000 ULTRASONIC WOUND THERAPY SYSTEMArobella Medical, LLC2007-01-031261

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