510(k) · Cleared
ClearedTransmyometrial Embryo Transfer Set
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 Feb 8, 1999 after a 118-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 8, 1999
- Review
- 118 days
- Class
- Class II
- Product code
- MQF
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983595 Transmyometrial Embryo Transfer SetCook Ob/Gyn · 1999
- Descendant · cites it directly · 0 of its ownK173431 Towako Transmyometrial Embryo Transfer SetWilliam A. Cook Australia Pty., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173431Towako Transmyometrial Embryo Transfer SetWilliam A. Cook Australia Pty., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983595 | Transmyometrial Embryo Transfer Set | Cook Ob/Gyn | 1999 | — |
| +1 | K173431 | Towako Transmyometrial Embryo Transfer Set | William A. Cook Australia Pty., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | — | Intra-Endometrial Embryo Transfer Set Named without a submission number |
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 |
|---|---|---|---|
| K173431 | Towako Transmyometrial Embryo Transfer Set | 2018 | 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?
- Of its descendants, K173431 (William A. Cook Australia Pty., Ltd., 2018) 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.
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 Transmyometrial Embryo Transfer Sets are used for transferring I'VF embryo (s) into the endometrial cavity through the myometrium. These devices are sterile and intended for onc time use. The Transmyometerial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted disease, a recent uterine perforation. ccrvical stenosis or other cervical abnormalities which would preclude embryo transfer. a recent cesarcan section, a recent pregnancy (or is currcatly pregnant), or if a patient currently has an intrauterine device.
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/K983595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983595: Transmyometrial Embryo Transfer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983595
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