510(k) · Cleared
ClearedSoules Intrauterine Insemination Catheter
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 Jul 14, 2017 as substantially equivalent to K061679 (Irvine Scientific Sales Co., Inc., 2006) after a 233-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Jul 14, 2017
- Review
- 233 days
- Class
- Class II
- Product code
- MQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K842231 (1984). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK842231 Ackrad Hysterosalpingography SetAckrad Laboratories · 1984
- 3 generations backK940176 Ackrad Iui Set for Intrauterine InseminationAckrad Laboratories · 1996
- 2 generations backK970492 Intrauterine Insemination and Sonohysterography CatheterAckrad Laboratories · 1997 · Recalled
- 1 generation backK061679 Wallace Artificial Insemination CatheterIrvine Scientific Sales Co., Inc. · 2006
- This deviceK163318 Soules Intrauterine Insemination CatheterCook Incorporated · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K842231 | Ackrad Hysterosalpingography Set | Ackrad Laboratories | 1984 | — |
| −3 | K940176 | Ackrad Iui Set for Intrauterine Insemination | Ackrad Laboratories | 1996 | — |
| −2 | K970492 | Intrauterine Insemination and Sonohysterography Catheter | Ackrad Laboratories | 1997 | 1 |
| −1 | K061679 | Wallace Artificial Insemination Catheter | Irvine Scientific Sales Co., Inc. | 2006 | — |
| 0 (this device) | K163318 | Soules Intrauterine Insemination Catheter | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K061679 | Wallace Artificial Insemination CatheterSummary page 4…LKF (Cannula, Manipulator/Injector, Uterine) Product Class: II Predicate Device: K061679 – Wallace SIS/AI Catheter (Irvine Scientific Sales Co., Inc.). This device has not been subject to a design-related recall.… | 2006 |
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 33 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K061679.
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?
The Soules Intrauterine Insemination Catheter is used to access the uterine cavity for saline infusion sonohysterography or
for the introduction of washed spermatozoa into the uterine cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163318 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163318: Soules Intrauterine Insemination Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163318
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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