510(k) · Cleared
ClearedIntrauterine Insemination (Iui) Catheter
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 Apr 2, 2010 as substantially equivalent to K032835 (Catheter Research, Inc., 2003) after a 228-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Apr 2, 2010
- Review
- 228 days
- Class
- Class II
- Product code
- MQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953034 (1995). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK953034 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1995
- 2 generations backK020951 H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model…Ackrad Laboratories · 2002 · Recalled
- 1 generation backK032835 H/S Catheter SetCatheter Research, Inc. · 2003 · Recalled
- This deviceK092579 Intrauterine Insemination (Iui) CatheterFertiligent, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK141666 Fertiligent Slow Release Iui Catheter KitFertiligent, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK120154 Intrauterine Insemination (Iui) CatheterCatheter Research, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953034 | H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | 1995 | — |
| −2 | K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007 | Ackrad Laboratories | 2002 | 1 |
| −1 | K032835 | H/S Catheter Set | Catheter Research, Inc. | 2003 | 1 |
| 0 (this device) | K092579 | Intrauterine Insemination (Iui) Catheter | Fertiligent, Ltd. | 2010 | — |
| +1 | K141666 | Fertiligent Slow Release Iui Catheter Kit | Fertiligent, Ltd. | 2015 | — |
| +1 | K120154 | Intrauterine Insemination (Iui) Catheter | Catheter Research, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 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 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 |
|---|---|---|---|
| * | K032835 | H/S Catheter SetSummary page 1…on Name: Assisted Reproduction Catheters; CFR 8 84.611 0 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: H/S Catheter K032835 Device Description: The R1JI Catheter is a balloon catheter for slow release insemination. The catheter is placed in the uterus… | 2003 |
What descends from it? (2)
2 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K141666 (Fertiligent, Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032835.
How does its category compare?
All MQF devicesMQF Catheter, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092579: Intrauterine Insemination (Iui) Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092579
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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