510(k) · Cleared
ClearedSQA-iO Sperm Quality Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Electronic Systems, Ltd. · POV Semen Analysis Device
Cleared on Aug 7, 2023 as substantially equivalent to K021746 (Medical Electronic Systems, LLC, 2002) after a 503-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Aug 7, 2023
- Review
- 503 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021746 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK021746 Sqa V, Sperm Quality AnalyzerMedical Electronic Systems, LLC · 2002
- This deviceK220828 SQA-iO Sperm Quality AnalyzerMedical Electronic Systems, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021746 | Sqa V, Sperm Quality Analyzer | Medical Electronic Systems, LLC | 2002 | — |
| 0 (this device) | K220828 | SQA-iO Sperm Quality Analyzer | Medical Electronic Systems, Ltd. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in POV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new POV device
- #1 K252228 Seaman Pro/Seamanscore 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021746 | Sqa V, Sperm Quality AnalyzerSummary page 4…ification of the legally marketed predicate devices SQA-iO is substantially equivalent to a predicate device, the SQA-V sperm analyzer, (MES Ltd., Israel), cleared under K021746, September 20, 2002. Both of these testing devices utilize fresh human sperm to measure a variety of male fertility factors. 807… | 2002 |
| † | K041600 | Qwikcheck-Beads | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K021746.
How does its category compare?
All POV devicesPOV Semen Analysis Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · POV
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POV
253in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · POV
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · POV
1in 2020
MAUDE reports naming product code POV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 3 | 253 | 2 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SQA-iO Sperm Quality Analyzer is an automated point-of-care in vitro use only medical device for semen analysis performed by healthcare professionals (trained lab technicians). The SQA-iO does not provide a comprehensive evaluation of a male’s fertility status. The SQA-iO provides direct and calculated quantitative measurements for the following parameters: Directly measured parameters: • Sperm Concentration, M/mL • Motile Sperm Concentration (MSC)…
Read the full statement (118 words)
The SQA-iO Sperm Quality Analyzer is an automated point-of-care in vitro use only medical device for semen analysis
performed by healthcare professionals (trained lab technicians). The SQA-iO does not provide a comprehensive
evaluation of a male’s fertility status.
The SQA-iO provides direct and calculated quantitative measurements for the following parameters:
Directly measured parameters:
• Sperm Concentration, M/mL
• Motile Sperm Concentration (MSC), M/mL
• Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapid and Slow PMSC, millions/mL)
• Normal Forms (Normal Morphology), %
Calculated parameters:
• Total Motility (PR + NP), %
• Progressive Motility (PR), % (combines Rapidly and Slowly Progressive Motility, %)
• Non-Progressive Motility (NP), %
• Immotile (IM), %
• Functional Sperm Concentration (FSC), millions/mL
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220828: SQA-iO Sperm Quality Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220828
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026