510(k) · Cleared
ClearedMini-Embryon Intra Uterine Insemination Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A & A Medical, Inc. · MFD Cannula, Intrauterine Insemination
Cleared on Oct 10, 1997 as substantially equivalent to K910577 (Marlo Surgical Technology, 1991) after a 72-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- Oct 10, 1997
- Review
- 72 days
- Class
- Class II
- Product code
- MFD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910577 (1991). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK910577 Edwards-Wallace Bourne Hall CatheterMarlo Surgical Technology · 1991
- This deviceK972823 Mini-Embryon Intra Uterine Insemination CatheterA & A Medical, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK982628 Medworks Insemination CatheterMedworks Corp. · 1998
- Descendant · cites it directly · 0 of its ownK021438 Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002
- Descendant · cites it directly · 0 of its ownK984306 `the Inseminator' (Proposed)Wallach Surgical Devices, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK982630 Medworks Visualization Insemination CatheterMedworks Corp. · 1999
Most influential descendants
Showing 4 of 4 · See all- K982628Medworks Insemination CatheterMedworks Corp. · 1998 · cites it directly1descendant
- K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002 · cites it directly0descendants
- K984306`the Inseminator' (Proposed)Wallach Surgical Devices, Inc. · 1999 · cites it directly0descendants
- K982630Medworks Visualization Insemination CatheterMedworks Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910577 | Edwards-Wallace Bourne Hall Catheter | Marlo Surgical Technology | 1991 | — |
| 0 (this device) | K972823 | Mini-Embryon Intra Uterine Insemination Catheter | A & A Medical, Inc. | 1997 | — |
| +1 | K982628 | Medworks Insemination Catheter | Medworks Corp. | 1998 | — |
| +1 | K021438 | Insemination Catheter, Model 320301 | Labotect Labor-Technik Gottingen | 2002 | — |
| +1 | K984306 | `the Inseminator' (Proposed) | Wallach Surgical Devices, Inc. | 1999 | — |
| +1 | K982630 | Medworks Visualization Insemination Catheter | Medworks Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 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? (6)
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 |
|---|---|---|---|
| * | K910577 | Edwards-Wallace Bourne Hall CatheterSummary page 2…systems, Inc F 510k zum ‘4-Conceptus, Inc. INTRAUTERINE : E|E|E|E|E|S|S |maneal E| E|waS| EfE neafneainea INSEMINATION CATHETER 5 10k| 5-Marlow Surgical ~ EDWARDS- k910577 |E|E[E|E|E|S|S |wajnal E|E [nealS| E | E |nranealna ‘WALLACE BOURNE-HALL Ay §B-Lab0ratoire ccd c/o Washington MENT SET Page… | 1991 |
| * | — | Seminor Named without a submission number | |
| * | — | Lifetek IUI Catheter Named without a submission number | |
| * | — | Select IUI Named without a submission number | |
| * | — | Intrauterine Insemination Catheter Named without a submission number | |
| * | — | Resubmitted Artificial Insemination Instrument set Named without a submission number |
What descends from it? (4)
4 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?
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?
The Mini Embryon Intrauterine Insemination catheter allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes.
This catheter is not intended for assisted reproduction procedures
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/K972823 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972823: Mini-Embryon Intra Uterine Insemination Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972823
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