510(k) · Cleared
ClearedPherDal® At-Home Insemination Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pherdal Fertility Science, Inc. · QYZ At Home Intravaginal Insemination System
Cleared on Dec 14, 2023 as substantially equivalent to K172321 (Cook Incorporated, 2017) after a 192-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Dec 14, 2023
- Review
- 192 days
- Class
- Class II
- Product code
- QYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K890301 (1989). 4 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 | K890301 | Shepard Intrauterine Insemination Catheter | Cook Ob/Gyn | 1989 | — |
| −1 | K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination… | Cook Incorporated | 2017 | — |
| 0 (this device) | K231645 | PherDal® At-Home Insemination Kit | Pherdal Fertility Science, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 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 QYZ? 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 QYZ device
- #1 K231203 Mosie Baby Kitscore 6.7 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination CathetersSummary page 5…ass II Product Code: QYZ (At Home Intravaginal Insemination System) IV. PREDICATE DEVICE Insemi-Cath® Intrauterine Insemination Catheter (K172321) This predicate device has not been subject to a design-related recall. V. DEVICE DESCRIPTION The PherDal® At-Home Insemi… | 2017 |
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 34 years and passes through 3 companies; a new generation was cleared every 28.7 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K172321.
How does its category compare?
All QYZ devicesQYZ At Home Intravaginal Insemination System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QYZ
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QYZ
192in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QYZ
No recall names QYZ since 2007.
Adverse event reports per year · QYZ
No MAUDE report names QYZ 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 | 3 | 192 | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PherDal® At-Home Insemination Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or have chosen not to conceive through intercourse, for semen collection and the delivery of semen to the vaginal canal. The PherDal® At-Home Insemination Kit should be used during the ovulatory phase of the menstrual cycle.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231645: PherDal® At-Home Insemination Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231645
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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