510(k) · Cleared
ClearedEmbryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet for Embryon Intrauter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rocket Medical Plc · MFD Cannula, Intrauterine Insemination
Cleared on Mar 2, 1998 as substantially equivalent to K894264 (Unimar, Inc., 1989) and 2 other predicates after a 54-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Mar 2, 1998
- Review
- 54 days
- Class
- Class II
- Product code
- MFD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K870551 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK870551 Intrauterine Insemination CatheterCook Ob/Gyn · 1987
- This deviceK980061 Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine…Rocket Medical Plc · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870551 | Intrauterine Insemination Catheter | Cook Ob/Gyn | 1987 | — |
| 0 (this device) | K980061 | Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine… | Rocket Medical Plc | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 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 MFD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K894264 | KDF-2.3Summary page 1…erce and have been submitted to the FDA. Such devices are the Insemination Cannula manufactured by Milex, the KDF-2.3 Intrauterine catheter manufactured by Unimar, D.C. #K894264, found substantially equivalent on August 15, 1989, the Intrauterine Insemination catheter manufactured by Cook OB/GYN, D.C. #K87… | 1989 |
| * | K870551 | Intrauterine Insemination CatheterSummary page 1…heter manufactured by Unimar, D.C. #K894264, found substantially equivalent on August 15, 1989, the Intrauterine Insemination catheter manufactured by Cook OB/GYN, D.C. #K870551, found substantially equivalent on March 2, 1987 and the Cook OB/GYN, Insemi-cath™ Insemination Catheter, #K931630 found substant… | 1987 |
| * | K931630 | Insemi-CathSummary page 1…semination catheter manufactured by Cook OB/GYN, D.C. #K870551, found substantially equivalent on March 2, 1987 and the Cook OB/GYN, Insemi-cath™ Insemination Catheter, #K931630 found substantially equivalent on April 19, 1994. The devices we believe are safe and effective for the application for which th… | 1994 |
| * | — | Insemination Cannula manufactured by Milex Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All MFD devicesMFD Cannula, Intrauterine Insemination: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MFD
FDA has decided no MFD device since 2007.
Median 510(k) review, days · MFD
Too few MFD 510(k)s in any year since 2007 to give a median.
Recalls per year · MFD
No recall names MFD since 2007.
Adverse event reports per year · MFD
1in 2022
MAUDE reports naming product code MFD, 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 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EMBRYON® Intra-uterine Insemination Catheters are purpose designed for the introduction of washed spermatazoa into the uterus,
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/K980061 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980061: Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet for Embryon Intrauter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980061
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