Mego Afek: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Mego Afek” (first 1981, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 56 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 49 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 56 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mego Afek took a median 52 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 5 | 5 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
Review panels
- Cardiovascular (5)
- Physical Medicine (1)
Most recent Mego Afek 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254267 | NanoPress 760A-BT (760A-BT) | JOW | 2026-02-24 | 56 |
| K230385 | Ballancer Platinum (1222) | IRP | 2023-04-04 | 49 |
| K072372 | PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE | JOW | 2007-11-21 | 90 |
| K060220 | PBS MODEL 701A COMPRESSION THERAPY DEVICE | JOW | 2006-02-09 | 10 |
| K013331 | LYMPHA PRESS PLUS DEVICE | JOW | 2001-11-30 | 56 |
| K810338 | LYMPHA PRESS | JOW | 1981-10-20 | 253 |
Recalls
openFDA lists no recalls under a recalling firm named Mego Afek.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Mego Afek is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00762086: Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II (Completed, started 2009-03)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mego Afek AC , Ltd. (17 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mego Afek?
FDA lists 6 510(k) clearances under the applicant name “Mego Afek” (first 1981, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mego Afek?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mego Afek is 56 days.
Which FDA product codes appear under Mego Afek?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 5); IRP (Massager, Powered Inflatable Tube, 1).
Next steps
- See all 6 Mego Afek clearances with predicates and recalls
- Run predicate analysis for product code JOW, Mego Afek's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.