Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mego Afek — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
253 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230385 | Ballancer Platinum (1222) | Mego Afek | 2023-04-04 | 49 | 0 |
| K072372 | PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE | Mego Afek | 2007-11-21 | 90 | 0 |
| K060220 | PBS MODEL 701A COMPRESSION THERAPY DEVICE | Mego Afek | 2006-02-09 | 10 | 0 |
| K013331 | LYMPHA PRESS PLUS DEVICE | Mego Afek | 2001-11-30 | 56 | 0 |
| K810338 | LYMPHA PRESS | Mego Afek | 1981-10-20 | 253 | 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