510(k) · Cleared
ClearedShepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · MQF Catheter, Assisted Reproduction
Cleared on Dec 21, 2017 as substantially equivalent to K890301 (Cook Ob/Gyn, 1989) and 2 other predicates after a 142-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Dec 21, 2017
- Review
- 142 days
- Class
- Class II
- Product code
- MQF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K890301 (1989). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK890301 Shepard Intrauterine Insemination CatheterCook Ob/Gyn · 1989
- This deviceK172321 Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine…Cook Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK231645 PherDal® At-Home Insemination KitPherdal Fertility Science, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK231203 Mosie Baby KitMosie Baby · 2023
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 |
|---|---|---|---|---|---|
| −1 | K890301 | Shepard Intrauterine Insemination Catheter | Cook Ob/Gyn | 1989 | — |
| 0 (this device) | K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination… | Cook Incorporated | 2017 | — |
| +1 | K231645 | PherDal® At-Home Insemination Kit | Pherdal Fertility Science, Inc. | 2023 | — |
| +1 | K231203 | Mosie Baby Kit | Mosie Baby | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K890301 | Shepard Intrauterine Insemination CatheterSummary page 4…Reproduction Device Class: Class II Classification Panel: Obstetrics/Gynecology Predicate Devices: Shepard IUI Catheter, K890301 Coaxial Catheter Set, K902694 Insemi-Cath II, K954398 The predicate devices have not been subject to a design-relat… | 1989 |
| * | K902694 | Coaxial Catheter SetSummary page 4…Class II Classification Panel: Obstetrics/Gynecology Predicate Devices: Shepard IUI Catheter, K890301 Coaxial Catheter Set, K902694 Insemi-Cath II, K954398 The predicate devices have not been subject to a design-related recall. Device Description: Shep… | 1990 |
| * | K954398 | Insemi-Cath IISummary page 4…cation Panel: Obstetrics/Gynecology Predicate Devices: Shepard IUI Catheter, K890301 Coaxial Catheter Set, K902694 Insemi-Cath II, K954398 The predicate devices have not been subject to a design-related recall. Device Description: Shepard Intrauterine Insemination S… | 1995 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K231645 (Pherdal Fertility Science, Inc., 2023) 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. 2017, 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?
Intrauterine Insemination Catheters are used for the introduction of washed spermatozoa into the uterine cavity.
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/K172321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172321: Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172321
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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