510(k) · Cleared
Recalled · Class II · 2017Intratubal Transfer 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. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 21, 1998
- Review
- 69 days
- Class
- Class II
- Product code
- MQF
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983591 Intratubal Transfer SetsCook Ob/Gyn · 1998
- Descendant · cites it directly · 0 of its ownK231730 FemaSeed Intratubal InseminationFemasys, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231730FemaSeed Intratubal InseminationFemasys, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983591 | Intratubal Transfer Sets | Cook Ob/Gyn | 1998 | — |
| +1 | K231730 | FemaSeed Intratubal Insemination | Femasys, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | — | Embryo and Gamete Intratubal Transfer Sets 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 |
|---|---|---|---|
| K231730 | FemaSeed Intratubal Insemination | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2017 | Class II | Z-1186-2018 | 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, K231730 (Femasys, Inc., 2023) 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 Intratubal Transfer Sets are used to inject either sperm, gametes or embryos into the uterine ostium of the fallopian tube via ultrasound guidance. The device is sterile and intended for one time use.
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/K983591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983591: Intratubal Transfer Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983591
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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