Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mego Afek AC , Ltd. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
169 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K214053 | Amputee Garment for use with Lympha Press Optimal Plus | Mego Afek AC , Ltd. | 2022-04-14 | 108 | 0 |
| K190493 | Recovery Pump, 737R (RPX) | Mego Afek AC , Ltd. | 2019-05-15 | 76 | 0 |
| K190015 | Ballancer Gold, 1212 | Mego Afek AC , Ltd. | 2019-03-25 | 81 | 0 |
| K182003 | Lympha Press Optimal Plus | Mego Afek AC , Ltd. | 2019-02-27 | 216 | 0 |
| K172277 | Phlebo Press DVT Model | Mego Afek AC , Ltd. | 2017-11-03 | 98 | 0 |
| K170658 | Lympha Press Optimal Plus | Mego Afek AC , Ltd. | 2017-05-31 | 89 | 0 |
| K163280 | RP Lite 760R | Mego Afek AC , Ltd. | 2017-01-27 | 67 | 0 |
| K150269 | Ballancer 505 System, Model 1201-AC | Mego Afek AC , Ltd. | 2015-05-26 | 111 | 0 |
| K142772 | Phlebo Press DVT 603 | Mego Afek AC , Ltd. | 2014-12-16 | 82 | 0 |
| K140519 | RECOVERY PUMP 737R | Mego Afek AC , Ltd. | 2014-06-16 | 108 | 0 |
| K140642 | PCD 737A | Mego Afek AC , Ltd. | 2014-06-10 | 90 | 0 |
| K131420 | PETITE BASIC SYSTEM 701 ELT | Mego Afek AC , Ltd. | 2013-11-01 | 169 | 0 |
| K121962 | PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B | Mego Afek AC , Ltd. | 2012-10-19 | 106 | 0 |
| K112479 | DSJ MASSAGER | Mego Afek AC , Ltd. | 2011-12-07 | 100 | 0 |
| K100677 | LYMPHA PRESS 201MAX, MODEL 201MAX | Mego Afek AC , Ltd. | 2010-05-20 | 71 | 0 |
| K100521 | COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTI | Mego Afek AC , Ltd. | 2010-05-14 | 80 | 0 |
| K082149 | LYMPHA PRESS OPTIMAL, MODEL# 1201AP | Mego Afek AC , Ltd. | 2008-10-06 | 68 | 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