510(k) · Cleared
ClearedIui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 a, B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynetics Medical Products NV · MQF Catheter, Assisted Reproduction
Cleared on Nov 30, 2001 after a 39-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Nov 30, 2001
- Review
- 39 days
- Class
- Class II
- Product code
- MQF
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK013501 Iui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 a, BGynetics Medical Products NV · 2001
- Descendant · cites it directly · 0 of its ownK112396 Iui CathetersKitazato Medical Co., Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K112396Iui CathetersKitazato Medical Co., Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013501 | Iui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 a, B | Gynetics Medical Products NV | 2001 | — |
| +1 | K112396 | Iui Catheters | Kitazato Medical Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112396 | Iui Catheters | 2012 | 0 |
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, K112396 (Kitazato Medical Co., Ltd., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MQF devicesMQF Catheter, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures utilizing washed spermatozoa.
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures utilizing washed spermatozoa.
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013501: Iui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 a, B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013501
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026