Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meta Biomed, 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) |
|---|---|---|---|---|---|
| K133298 | ENDO SMART | Meta Biomed, Inc. | 2014-09-19 | 329 | 0 |
| K134008 | MD-FLEX HEAVY BODY | Meta Biomed, Inc. | 2014-04-09 | 100 | 0 |
| K132041 | REXTAR X | Meta Biomed, Inc. | 2013-07-31 | 29 | 0 |
| K122016 | REXTAR, REXTAR LCD | Meta Biomed, Inc. | 2013-03-01 | 234 | 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