Medical Electronic Systems , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medical Electronic Systems , Ltd.” (first 2001, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 160 days. Since 2017 the median was 214 days, against 234 days for all cleared 510(k)s in the same product codes. 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 | 1 | 160 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 503 |
| 2024 | 1 | 176 |
| 2025 | 1 | 214 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medical Electronic Systems , Ltd. took a median 214 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 234 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| POV | Semen Analysis Device | 7 | 7 |
Review panels
- Hematology (7)
Most recent Medical Electronic Systems , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243114 | SQA-iOw Sperm Quality Analyzer | POV | 2025-05-02 | 214 |
| K241628 | YO Home Sperm Test | POV | 2024-11-29 | 176 |
| K220828 | SQA-iO Sperm Quality Analyzer | POV | 2023-08-07 | 503 |
| K161493 | YO Home Sperm Test | POV | 2016-11-08 | 160 |
| K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | POV | 2007-03-26 | 87 |
| K021746 | SQA V, SPERM QUALITY ANALYZER | POV | 2002-09-20 | 115 |
| K012352 | SQA, SPERM QUALITY ANALYZER | POV | 2001-09-21 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Electronic Systems , Ltd..
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.
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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Electronic Systems , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Medical Electronic Systems , Ltd.” (first 2001, latest 2025), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medical Electronic Systems , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Electronic Systems , Ltd. is 160 days. Since 2017: 214 days, versus 234 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medical Electronic Systems , Ltd.?
The most frequent FDA product codes under this applicant name are POV (Semen Analysis Device, 7).
Next steps
- See all 7 Medical Electronic Systems , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code POV, Medical Electronic Systems , Ltd.'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.