510(k) · Cleared
ClearedIvos Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamilton Thorne Research · GKL Counter, Cell, Automated (Particle Counter)
Cleared on Jun 29, 1992 after a 132-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- Jun 29, 1992
- Review
- 132 days
- Class
- Class II
- Product code
- GKL
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK920719 Ivos AnalyzerHamilton Thorne Research · 1992
- Descendant · cites it directly · 7 of its ownK041039 Fertell Male Fertility TestGenosis, Ltd. · 2004
- Descendant · 2 generations on · 5 of its ownK073039 Spermcheck VasectomyPrinceton BioMeditech Corp. · 2008
- Descendant · 2 generations on · 4 of its ownK100341 Spermcheck FertilityPrinceton BioMeditech Corp. · 2010
- Descendant · 3 generations on · 1 of its ownK161493 YO Home Sperm TestMedical Electronic Systems, Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK153683 Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K041039Fertell Male Fertility TestGenosis, Ltd. · 2004 · cites it directly7descendants
- K073039Spermcheck VasectomyPrinceton BioMeditech Corp. · 2008 · 2 generations on5descendants
- K100341Spermcheck FertilityPrinceton BioMeditech Corp. · 2010 · 2 generations on4descendants
- K161493YO Home Sperm TestMedical Electronic Systems, Ltd. · 2016 · 3 generations on1descendant
- K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920719 | Ivos Analyzer | Hamilton Thorne Research | 1992 | — |
| +1 | K041039 | Fertell Male Fertility Test | Genosis, Ltd. | 2004 | — |
| +2 | K073039 | Spermcheck Vasectomy | Princeton BioMeditech Corp. | 2008 | — |
| +2 | K100341 | Spermcheck Fertility | Princeton BioMeditech Corp. | 2010 | — |
| +3 | K161493 | YO Home Sperm Test | Medical Electronic Systems, Ltd. | 2016 | — |
| +3 | K153683 | Trak Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K041039 (Genosis, Ltd., 2004) has gone furthest, with 7 descendants of its own.
How does its category compare?
All GKL devicesGKL Counter, Cell, Automated (Particle Counter): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKL
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GKL
Too few GKL 510(k)s in any year since 2007 to give a median.
Recalls per year · GKL
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKL
1in 2025
MAUDE reports naming product code GKL, 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 | 1 | — | 1 | 25 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K920719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920719: Ivos Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920719
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026