Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Electronic Systems , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
176 daysmedian FDA review time
503 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | 2025-05-02 | 214 | 0 |
| K241628 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2024-11-29 | 176 | 0 |
| K220828 | SQA-iO Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | 2023-08-07 | 503 | 0 |
| K161493 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2016-11-08 | 160 | 0 |
| K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | Medical Electronic Systems , Ltd. | 2007-03-26 | 87 | 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