510(k) · Cleared
ClearedMicrospan Insemination System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imagyn Medical, Inc. · MFD Cannula, Intrauterine Insemination
Cleared on May 5, 1997 after a 63-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- May 5, 1997
- Review
- 63 days
- Class
- Class II
- Product code
- MFD
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970750 Microspan Insemination SystemImagyn Medical, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK982630 Medworks Visualization Insemination CatheterMedworks Corp. · 1999
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K970750 | Microspan Insemination System | Imagyn Medical, Inc. | 1997 | — |
| +1 | K982630 | Medworks Visualization Insemination Catheter | Medworks Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (5)
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 |
|---|---|---|---|
| * | — | Imagyn Intrauterine Insemination Device Named without a submission number | |
| * | — | Cook OB/GYN Coaxial Catheter Set Named without a submission number | |
| * | — | Cook OB/GYN Shepard Intrauterine Insemination Catheter Named without a submission number | |
| * | — | Cook OB/GYN Jansen-Anderson Insemination Set Named without a submission number | |
| * | — | Cook OB/GYN Spirtos Coaxial Catheter 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 |
|---|---|---|---|
| K982630 | Medworks Visualization Insemination Catheter | 1999 | 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, K982630 (Medworks Corp., 1999) has gone furthest, with 0 descendants of its own.
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?
Used for intrauterine insemination. The MicroSpan Delivery Catheter is designed to fit through the larger diameter MicroSpan Access Catheter for delivery of washed spermatozoa to the uterine cavity or for laparoscopic instillation and/or aspiration of media. Laparoscopically, the device is specifically intended for use to aspirate ascitic fluids, aspirate fluid from the cul-de-sac for cytologic screening and bacteriologic cultures, irrigation and…
Read the full statement (98 words)
Used for intrauterine insemination. The MicroSpan Delivery Catheter is designed to fit through the larger diameter MicroSpan Access Catheter for delivery of washed spermatozoa to the uterine cavity or for laparoscopic instillation and/or aspiration of media. Laparoscopically, the device is specifically intended for use to aspirate ascitic fluids, aspirate fluid from the cul-de-sac for cytologic screening and bacteriologic cultures, irrigation and aspiration of larger volumes of fluid from ovarian tumors, irrigation and rinsing of the operative field, aspiration of bloody fluid resulting from a tubal pregnancy or post operative bleeding, and instillation of sterile saline or Ringer’s solution.
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/K970750 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970750: Microspan Insemination System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970750
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