510(k) · Cleared
ClearedMedworks Insemination Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medworks Corp. · MFD Cannula, Intrauterine Insemination
Cleared on Aug 21, 1998 as substantially equivalent to K884696 (Laboratoire Ccd C/O Washington Regulatory Services, 1989) and 2 other predicates after a 24-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Aug 21, 1998
- Review
- 24 days
- Class
- Class II
- Product code
- MFD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K910577 (1991). 4 ancestors in all, the oldest K884696 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK910577 Edwards-Wallace Bourne Hall CatheterMarlo Surgical Technology · 1991
- 1 generation backK972823 Mini-Embryon Intra Uterine Insemination CatheterA & A Medical, Inc. · 1997
- This deviceK982628 Medworks Insemination CatheterMedworks Corp. · 1998
- Descendant · cites it directly · 0 of its ownK021438 Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002
Most influential descendants
Showing 1 of 1 · See all- K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910577 | Edwards-Wallace Bourne Hall Catheter | Marlo Surgical Technology | 1991 | — |
| −1 | K972823 | Mini-Embryon Intra Uterine Insemination Catheter | A & A Medical, Inc. | 1997 | — |
| 0 (this device) | K982628 | Medworks Insemination Catheter | Medworks Corp. | 1998 | — |
| +1 | K021438 | Insemination Catheter, Model 320301 | Labotect Labor-Technik Gottingen | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K884696 | Resubmitted Artificial Insemination Instrument SetSummary page 1…f the Federal Food. Drug. and Cosmetic Act. the device classification is Class II. Predicate Devices: Roseff"s Double Lumen Standard Intrauterine Insemination Catheter (K884696) Fertility Technologies, Inc. Mini-Embryon Intra Uterine Insemination Catheter (K972823) A& A Medical, Inc. Standard Intrauteri… | 1989 |
| * | K972823 | Mini-Embryon Intra Uterine Insemination CatheterSummary page 1…cate Devices: Roseff"s Double Lumen Standard Intrauterine Insemination Catheter (K884696) Fertility Technologies, Inc. Mini-Embryon Intra Uterine Insemination Catheter (K972823) A& A Medical, Inc. Standard Intrauterine Insemination Catheter (K884696) CCD International Jansen-Anderson Insemination Set (K… | 1997 |
| * | K914150 | Jansen-Anderson Insemination SetSummary page 1…ra Uterine Insemination Catheter (K972823) A& A Medical, Inc. Standard Intrauterine Insemination Catheter (K884696) CCD International Jansen-Anderson Insemination Set (K914150) Cook Ob/Gyn Product Description: Malleable catheter with distal side ports and balloon to help position the catheter at the ba… | 1992 |
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 |
|---|---|---|---|
| K021438 | Insemination Catheter, Model 320301 | 2002 | 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K021438 (Labotect Labor-Technik Gottingen, 2002) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K884696.
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?
For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.
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/K982628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982628: Medworks 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/K982628
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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