Atlas FDA

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

Maxtec, LLC — Predicate Candidate Screening

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

172 daysmedian FDA review time
290 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K231895Maxtec MaxBlend2+pMaxtec, LLC2023-12-041590
K221734Maxtec MaxO2 ME+pMaxtec, LLC2023-04-012900
K182362MaxCap Ped and MaxCap NeoMaxtec, LLC2019-05-232660
K161718MaxBlend 2, MaxBlend LiteMaxtec, LLC2016-10-271270
K153659MaxO2MEMaxtec, LLC2016-06-101720
K112402ULTRAMAXO2 OXYGEN ANALYERMaxtec, LLC2011-12-141140

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