Atlas FDA

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

Amo Manufacturing USA, LLC · Predicate Candidate Screening

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

99 daysmedian FDA review time
181 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC2023-04-121110
K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC2022-05-17830
K210701CATALYS Precision Laser SystemAmo Manufacturing USA, LLC2021-04-07290
K182083Catalys Precision Laser SystemAmo Manufacturing USA, LLC2018-11-09990
K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC2017-08-25530
K141852IFS ADVANCED FEMTOSECOND LASER SYSTEMAmo Manufacturing USA, LLC2015-01-061810

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