510(k) · Cleared
ClearedKitazato Iui Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kitazato Medical Co., Ltd. · MQF Catheter, Assisted Reproduction
Cleared on Sep 11, 2013 as substantially equivalent to K061679 (Irvine Scientific Sales Co., Inc., 2006) after a 111-day review. Its family tree reaches back 4 generations to 1984. 1 later device descends from it.
- Decided
- Sep 11, 2013
- Review
- 111 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. 1 later device descends from it, 1 citing it directly.
- 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 deviceK131491 Kitazato Iui CatheterKitazato Medical Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK162667 Kitazato IUI CatheterKitazato Corporation · 2017
Most influential descendants
Showing 1 of 1 · See all- K162667Kitazato IUI CatheterKitazato Corporation · 2017 · cites it directly0descendants
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) | K131491 | Kitazato Iui Catheter | Kitazato Medical Co., Ltd. | 2013 | — |
| +1 | K162667 | Kitazato IUI Catheter | Kitazato Corporation | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K061679 | Wallace Artificial Insemination CatheterSummary page 1…lass: 11 Classification Panel: Obstetrics/Gynecology 5. Predicate Devices Irvine Scientific Sales Co., Inc. - Wallace SIS/Al Catheter - K061679 5-1… | 2006 |
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 |
|---|---|---|---|
| K162667 | Kitazato IUI Catheter | 2017 | 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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K162667 (Kitazato Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 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. 2013, 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?
Kitazato IUI Catheter consist of the following versions:
Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number Type 3-v1
Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18 cm, model number Type 3-v2
Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131491: Kitazato 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/K131491
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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