510(k) · Cleared
ClearedFertiligent Slow Release Iui Catheter Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fertiligent, Ltd. · MQF Catheter, Assisted Reproduction
Cleared on Feb 3, 2015 as substantially equivalent to K092579 (Fertiligent, Ltd., 2010) after a 225-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Feb 3, 2015
- Review
- 225 days
- Class
- Class II
- Product code
- MQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953034 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK953034 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1995
- 3 generations backK020951 H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model…Ackrad Laboratories · 2002 · Recalled
- 2 generations backK032835 H/S Catheter SetCatheter Research, Inc. · 2003 · Recalled
- 1 generation backK092579 Intrauterine Insemination (Iui) CatheterFertiligent, Ltd. · 2010
- This deviceK141666 Fertiligent Slow Release Iui Catheter KitFertiligent, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953034 | H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | 1995 | — |
| −3 | K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007 | Ackrad Laboratories | 2002 | 1 |
| −2 | K032835 | H/S Catheter Set | Catheter Research, Inc. | 2003 | 1 |
| −1 | K092579 | Intrauterine Insemination (Iui) Catheter | Fertiligent, Ltd. | 2010 | — |
| 0 (this device) | K141666 | Fertiligent Slow Release Iui Catheter Kit | Fertiligent, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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 MQF? 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 MQF device
- #1 K253354 Minvitro Embryo Transfer Catheters (ETCA23175…score 11.4 · 3 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 |
|---|---|---|---|
| * | K092579 | Intrauterine Insemination (Iui) CatheterSummary page 4…Product Code: MQF Legally Marketed Devices to Which Substantial Equivalence Is Claimed: Fertiligent Slow Release IUI Catheter Kit K092579 Device Description: The subject device is a balloon catheter for slow release intrauterine insemination. The catheter is placed… | 2010 |
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 20 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K092579.
How does its category compare?
All MQF devicesMQF Catheter, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MQF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQF
196in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQF
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQF
13in 2025
MAUDE reports naming product code MQF, 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 | 0 | — | 6 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 6 | 230 | 0 | 10 |
| 2018 | 5 | 196 | 0 | 27 |
| 2019 | 2 | — | 2 | 16 |
| 2020 | 2 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 11 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 1 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Delivery of approximately 1ml of sperm into the uterus over 3-4 hours using a controlled release pump.
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/K141666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141666: Fertiligent Slow Release Iui Catheter Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141666
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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