510(k) · Cleared
Recalled · Class III · 2020Wallace Artificial Insemination Catheter - 8CM/18CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marlow Surgical Technologies, Inc. · MFD Cannula, Intrauterine Insemination
Cleared on Jan 16, 1997 after a 44-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled once.
- Decided
- Jan 16, 1997
- Review
- 44 days
- Class
- Class II
- Product code
- MFD
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK964848 Wallace Artificial Insemination Catheter - 8CM/18CMMarlow Surgical Technologies, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK061679 Wallace Artificial Insemination CatheterIrvine Scientific Sales Co., Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK131491 Kitazato Iui CatheterKitazato Medical Co., Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK163318 Soules Intrauterine Insemination CatheterCook Incorporated · 2017
- Descendant · 3 generations on · 0 of its ownK162667 Kitazato IUI CatheterKitazato Corporation · 2017
- Descendant · cites it directly · 0 of its ownK023383 Coopersurgical Intrauterine Insemination CatheterCooper Surgical · 2002
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061679Wallace Artificial Insemination CatheterIrvine Scientific Sales Co., Inc. · 2006 · cites it directly3descendants
- K131491Kitazato Iui CatheterKitazato Medical Co., Ltd. · 2013 · 2 generations on1descendant
- K163318Soules Intrauterine Insemination CatheterCook Incorporated · 2017 · 2 generations on0descendants
- K162667Kitazato IUI CatheterKitazato Corporation · 2017 · 3 generations on0descendants
- K023383Coopersurgical Intrauterine Insemination CatheterCooper Surgical · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964848 | Wallace Artificial Insemination Catheter - 8CM/18CM | Marlow Surgical Technologies, Inc. | 1997 | — |
| +1 | K061679 | Wallace Artificial Insemination Catheter | Irvine Scientific Sales Co., Inc. | 2006 | — |
| +2 | K131491 | Kitazato Iui Catheter | Kitazato Medical Co., Ltd. | 2013 | — |
| +2 | K163318 | Soules Intrauterine Insemination Catheter | Cook Incorporated | 2017 | — |
| +3 | K162667 | Kitazato IUI Catheter | Kitazato Corporation | 2017 | — |
| +1 | K023383 | Coopersurgical Intrauterine Insemination Catheter | Cooper Surgical | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | — | Edwards-Wallace AIC Catheters Named without a submission number |
What descends from it? (6)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2020 | Class III | Z-1713-2020 | Labeling Change Control | Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061679 (Irvine Scientific Sales Co., Inc., 2006) has gone furthest, with 3 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 Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.
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/K964848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964848: Wallace Artificial Insemination Catheter - 8CM/18CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964848
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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