510(k) · Cleared
ClearedTom Cat F.L., Tom Cat S.L.
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 Aug 6, 1997 after a 51-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Aug 6, 1997
- Review
- 51 days
- Class
- Class II
- Product code
- MFD
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK972245 Tom Cat F.L., Tom Cat S.L.A & A Medical, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK984306 `the Inseminator' (Proposed)Wallach Surgical Devices, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K984306`the Inseminator' (Proposed)Wallach Surgical Devices, Inc. · 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) | K972245 | Tom Cat F.L., Tom Cat S.L. | A & A Medical, Inc. | 1997 | — |
| +1 | K984306 | `the Inseminator' (Proposed) | Wallach Surgical Devices, Inc. | 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? (20)
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 |
|---|---|---|---|
| * | — | Malkler Insemination Device Named without a submission number | |
| * | — | CSI Insemination Instrument and Sheath Named without a submission number | |
| * | — | Oligospermis Cup Named without a submission number | |
| * | — | Cervical Cap Named without a submission number | |
| * | — | Seminor Named without a submission number | |
| * | — | Uni-Sem Named without a submission number | |
| * | — | Jansen-Anderson Insemination Set Named without a submission number | |
| * | — | Lifetek IUI Catheter Named without a submission number | |
| * | — | Insemi-Cath Named without a submission number | |
| * | — | Select IUI Named without a submission number | |
| * | — | Insemi-Cath II Named without a submission number | |
| * | — | Genxcatheter Named without a submission number | |
| * | — | Wallace Artificial Insemination catheter- 8CM/18C M Named without a submission number | |
| * | — | Intrauterine Insemination Catheter Named without a submission number | |
| * | — | Insemi-Cath Insemination catheter Named without a submission number | |
| * | — | Edwards-Wallace Bourne-Hall Named without a submission number | |
| * | — | Intrauterine Insemination and Sonohysterography catheter Named without a submission number | |
| * | — | Resubmitted Artificial Insemination Instrument set Named without a submission number | |
| * | — | Shepard Intrauterine Insemination catheter Named without a submission number | |
| * | — | Minispace IUI Catheter 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 |
|---|---|---|---|
| K984306 | `the Inseminator' (Proposed) | 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, K984306 (Wallach Surgical Devices, Inc., 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?
The TomCat 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 can handle washed sperm to be delivered into the uterine cavity.
This device 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/K972245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972245: Tom Cat F.L., Tom Cat S.L..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972245
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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