510(k) · Cleared
Recalled · Class II · 2019Embryo Transfer Catheters/Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ob/Gyn · MQF Catheter, Assisted Reproduction
Cleared on Dec 21, 1998 after a 69-day review. The FDA summary names its predicate without a number. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 21, 1998
- Review
- 69 days
- Class
- Class II
- Product code
- MQF
- Recalls
- 3
- Predicates
- 0
14 later devices descend from it, 6 citing it directly.
- This deviceK983594 Embryo Transfer Catheters/SetsCook Ob/Gyn · 1998
- Descendant · cites it directly · 5 of its ownK033084 Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer…Portex, Ltd. · 2003 · Recalled
- Descendant · 2 generations on · 2 of its ownK162878 Kitazato ET CathetersKitazato Corporation · 2017
- Descendant · cites it directly · 1 of its ownK173103 Pivet and Soft-Pass Embryo Transfer Catheter SetsCook Incorporated · 2018
- Descendant · cites it directly · 1 of its ownK173686 Guardia Access Embryo Transfer Catheter Sets and Sydney IVF®…Cook Incorporated · 2018
- Descendant · cites it directly · 1 of its ownK172051 Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets…Cook Incorporated · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K033084Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer CatheterPortex, Ltd. · 2003 · cites it directly5descendants
- K162878Kitazato ET CathetersKitazato Corporation · 2017 · 2 generations on2descendants
- K173103Pivet and Soft-Pass Embryo Transfer Catheter SetsCook Incorporated · 2018 · cites it directly1descendant
- K173686Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer CatheterCook Incorporated · 2018 · cites it directly1descendant
- K172051Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo…Cook Incorporated · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983594 | Embryo Transfer Catheters/Sets | Cook Ob/Gyn | 1998 | — |
| +1 | K033084 | Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter | Portex, Ltd. | 2003 | 6 |
| +2 | K162878 | Kitazato ET Catheters | Kitazato Corporation | 2017 | — |
| +1 | K173103 | Pivet and Soft-Pass Embryo Transfer Catheter Sets | Cook Incorporated | 2018 | — |
| +1 | K173686 | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter | Cook Incorporated | 2018 | — |
| +1 | K172051 | Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans… | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Cook Australia Embryo Transfer Catheters/Sets Named without a submission number |
What descends from it? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033084 | Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter | 2003 | 5 |
| K173103 | Pivet and Soft-Pass Embryo Transfer Catheter Sets | 2018 | 1 |
| K173686 | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter | 2018 | 1 |
| K172051 | Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo… | 2018 | 1 |
| K180302 | Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator… | 2018 | 0 |
| K994327 | Embryon Transfer Catheters/Sets | 2000 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2019 | Class II | Z-0415-2020 | Under Investigation by firm | Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need… |
| Oct 3, 2019 | Class II | Z-0416-2020 | Under Investigation by firm | Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need… |
| Dec 19, 2017 | Class II | Z-1188-2018 | Process control | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033084 (Portex, Ltd., 2003) has gone furthest, with 5 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 Embryo Transfer Catheters/Sets are used to place embryos 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/K983594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983594: Embryo Transfer Catheters/Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983594
Report an extraction error
Are you the manufacturer?
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