510(k) · Cleared
ClearedSemen Analysis Quality Control, Assayed and Unassayed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fertility Solutions, Inc. · NRF Material, Quality Control, Semen Analysis
Cleared on Jun 2, 2004 as substantially equivalent to K993825 (Streck Laboratories, Inc., 1999) and 3 other predicates after a 22-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jun 2, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- NRF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K896154 (1989). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896154 | Para Tech for Technicon H-1 | Streck Laboratories, Inc. | 1989 | — |
| −1 | K993825 | Para Tech Plus Retics | Streck Laboratories, Inc. | 1999 | 3 |
| 0 (this device) | K041240 | Semen Analysis Quality Control, Assayed and Unassayed | Fertility Solutions, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
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 NRF? 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? (4)
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 |
|---|---|---|---|
| * | K993825 | Para Tech Plus ReticsSummary page 2…d suspension of stabilized human red blood cells, human white blood cells, simulated human platelets, and simulated human reticulocytes. 510K# K993825 * The Synovialscopics Control sold by Quantimetrix Corp., which is supplied in two levels as a liquid human source m… | 1999 |
| * | K010598 | Synovialscopics, Synovial Fluid ControlSummary page 2…uman red blood cells and human white blood cells, other chemicals and non-protein materials have been added by the manufacturer. 510K# K010598 • The R&D Body Fluid Control sold by R&D Systems, Inc., which is supplied in two levels as a liquid containing stabi… | 2001 |
| * | K020229 | R & D Body Fluid ControlSummary page 2…iquid containing stabilized human red blood cells and human white blood cells, simulating cells and body fluids in morphology and count. 510K# K020229 * The 81JPD Hematology Control sold by R&D Systems, Inc., which is supplied in three levels as a plasma-like liquid… | 2002 |
| * | K010409 | CBC-SFSummary page 2…, mammalian leukocytes, mammalian platelets, and other chemicals and non-protein materials have been added by the manufacturer. 510K# K010409 Description: AQCTM Sperm Count and AQCTM Post-Vasectomy Quality Controls are supplied in two levels, 0.3mL per vial. AQCTM Sperm… | 2001 |
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All NRF devicesNRF Material, Quality Control, Semen Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRF
FDA has decided no NRF device since 2007.
Median 510(k) review, days · NRF
Too few NRF 510(k)s in any year since 2007 to give a median.
Recalls per year · NRF
No recall names NRF since 2007.
Adverse event reports per year · NRF
No MAUDE report names NRF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AQCTM Sperm Count and AQCTM Post-vasectomy Quality Controls are intended for monitoring sperm counts performed either manually using commercially available counting chambers or using computer assisted semen analysis (CASA) instruments. The AQCTM Sperm Count and AQCTM Post-vasectomy Quality Controls are intended for use as Quality Control materials having known sperm concentrations. Daily monitoring of the control values establishes intralaboratory…
Read the full statement (101 words)
The AQCTM Sperm Count and AQCTM Post-vasectomy Quality Controls are intended for monitoring sperm counts performed either manually using commercially available counting chambers or using computer assisted semen analysis (CASA) instruments. The AQCTM Sperm Count and AQCTM Post-vasectomy Quality Controls are intended for use as Quality Control materials having known sperm concentrations. Daily monitoring of the control values establishes intralaboratory parameters for accuracy and precision of the cell counting methods. These products are also available for external laboratory quality control and proficiency testing and as such are sold under the proprietary trade names, AQCTM Sperm Count and AQCTM Post-Vasectomy Proficiency Challenges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041240: Semen Analysis Quality Control, Assayed and Unassayed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041240
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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