Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Maxtec, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133540 | FLOCAP | Maxtec, Inc. | 2014-03-28 | 130 | 0 |
| K113232 | MAXMIXING BLOCK | Maxtec, Inc. | 2012-03-01 | 120 | 0 |
| K063488 | MAXO2 CU | Maxtec, Inc. | 2007-02-22 | 97 | 0 |
| K040484 | MAXO2+, MODEL A AND AE | Maxtec, Inc. | 2004-06-09 | 105 | 0 |
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