510(k) · Cleared
ClearedKitazato ET Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kitazato Corporation · MQF Catheter, Assisted Reproduction
Cleared on Jul 13, 2017 as substantially equivalent to K033084 (Portex, Ltd., 2003) after a 272-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Jul 13, 2017
- Review
- 272 days
- Class
- Class II
- Product code
- MQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983594 (1998). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK983594 Embryo Transfer Catheters/SetsCook Ob/Gyn · 1998 · Recalled
- 1 generation backK033084 Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer…Portex, Ltd. · 2003 · Recalled
- This deviceK162878 Kitazato ET CathetersKitazato Corporation · 2017
- Descendant · cites it directly · 0 of its ownK253354 Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C…Guangzhou Hehong Biotech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243373 Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo…Vitrolife Sweden AB · 2025
Most influential descendants
Showing 2 of 2 · See all- K253354Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C…Guangzhou Hehong Biotech Co., Ltd. · 2026 · cites it directly0descendants
- K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -…Vitrolife Sweden AB · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983594 | Embryo Transfer Catheters/Sets | Cook Ob/Gyn | 1998 | 3 |
| −1 | K033084 | Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter | Portex, Ltd. | 2003 | 6 |
| 0 (this device) | K162878 | Kitazato ET Catheters | Kitazato Corporation | 2017 | — |
| +1 | K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175… | Guangzhou Hehong Biotech Co., Ltd. | 2026 | — |
| +1 | K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter… | Vitrolife Sweden AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K033084 | Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer CatheterSummary page 5…K162878 Device Class: Class II Classification Panel: Obstetrics/Gynecology 5. Legally Marketed Predicate Device(s) K033084 - Portex, Ltd. Wallace Embryo Replacement Catheters and Trial Transfer Catheters The predicate device was subject to a design… | 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 19 years and passes through 3 companies; a new generation was cleared every 13.6 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K253354 (Guangzhou Hehong Biotech Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K033084.
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 Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation.
Kitazato ET Catheters are provided in various configurations (Type 1 through Type 5), which consist of the following components:
• Transfer Catheter, for delivery of embryos into the uterine cavity;
• Guide Catheter, to guide the insertion of the Transfer Catheter and reinforce it during use:
• Trial Catheter, used to confirm the curvature of the cervix and if the cervix is passable;
• Stylet Sheath, used to increase the strength of the Guide Catheter during insertion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162878: Kitazato ET Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162878
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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