510(k) · Cleared
ClearedWallace Artificial Insemination Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Scientific Sales Co., Inc. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Oct 13, 2006 as substantially equivalent to K842231 (Ackrad Laboratories, 1984) and 6 other predicates after a 120-day review. Its family tree reaches back 3 generations to 1984. 3 later devices descend from it.
- Decided
- Oct 13, 2006
- Review
- 120 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K842231 (1984). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK842231 Ackrad Hysterosalpingography SetAckrad Laboratories · 1984
- 2 generations backK940176 Ackrad Iui Set for Intrauterine InseminationAckrad Laboratories · 1996
- 1 generation backK970492 Intrauterine Insemination and Sonohysterography CatheterAckrad Laboratories · 1997 · Recalled
- This deviceK061679 Wallace Artificial Insemination CatheterIrvine Scientific Sales Co., Inc. · 2006
- Descendant · cites it directly · 1 of its ownK131491 Kitazato Iui CatheterKitazato Medical Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK163318 Soules Intrauterine Insemination CatheterCook Incorporated · 2017
- Descendant · 2 generations on · 0 of its ownK162667 Kitazato IUI CatheterKitazato Corporation · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842231 | Ackrad Hysterosalpingography Set | Ackrad Laboratories | 1984 | — |
| −2 | K940176 | Ackrad Iui Set for Intrauterine Insemination | Ackrad Laboratories | 1996 | — |
| −1 | K970492 | Intrauterine Insemination and Sonohysterography Catheter | Ackrad Laboratories | 1997 | 1 |
| 0 (this device) | K061679 | Wallace Artificial Insemination Catheter | Irvine Scientific Sales Co., Inc. | 2006 | — |
| +1 | K131491 | Kitazato Iui Catheter | Kitazato Medical Co., Ltd. | 2013 | — |
| +1 | K163318 | Soules Intrauterine Insemination Catheter | Cook Incorporated | 2017 | — |
| +2 | K162667 | Kitazato IUI Catheter | Kitazato Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LKF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LKF device
- #1 K241693 FemChec Controlled Saline-Air Device (FCD-250)score 11.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K842231 | Ackrad Hysterosalpingography SetSummary page 3…June 7, 2006 kj s< Applicant Product Name K# Address ACKRAD Hysterosalpingorgraphy Set K842231 70 Jackson Dr. Laboratories Cranford, NJ 07016 ACKRAD… | 1984 |
| * | K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007Summary page 3…Dr. ~~~~~~~~~~~Jackson Laboratories Hysterosalpingography or K020951 ranford, NJ 07016 hysterosonographv ACKRAD Intrauterine Insemination… | 2002 |
| * | K970492 | Intrauterine Insemination and Sonohysterography CatheterSummary page 3…hysterosonographv ACKRAD Intrauterine Insemination 70 Jackson Dr. Laboratories and Sonohysterography K970492 Cranford, NJ 07016 Bard Hysterosalpingography 1 0 Federal St. P.O. Box… | 1997 |
| * | K890869 | Bard Hysterosalpingography CathetersSummary page 3…aphy 1 0 Federal St. P.O. Box ~~~5 C.R. Bard, INC. Catheters I K890869 5069 Billerica, MA 01822 Bioteque HSG C… | 1989 |
| * | K041094 | HSG Catheter SetSummary page 3…01822 Bioteque HSG Catheter Set 340 East Maple Ave., America, Inc. Infusion of contrast dye or K041094 #204-C sterile saline Langhorne, PA 19047 Modern Medical Soft… | 2004 |
| * | K040238 | Softseal HSG CatheterSummary page 3…Langhorne, PA 19047 Modern Medical Softseal HSG Catheter 1705 Dabney Rd. Equipment MFG., K040238 LTD. Sonohysterography Richmond, VA 23230 Marlow Surgical Wallace Artifici… | 2004 |
| * | K964848 | Wallace Artificial Insemination Catheter - 8CM/18CMSummary page 1…terine, (Unclassified, Class 11,Product Code 85 LKF) Description: The Wallace Artificial Insemination Catheter (K964848) is a single-use, sterile, disposable device that was originally submitted and cleared with the intended use for insertion of… | 1997 |
What descends from it? (3)
2 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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K131491 (Kitazato Medical Co., Ltd., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K842231.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LKF
136in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LKF
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKF
95in 2025
MAUDE reports naming product code LKF, 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 | 3 | 141 | 0 | 36 |
| 2008 | 0 | — | 2 | 59 |
| 2009 | 2 | — | 0 | 53 |
| 2010 | 6 | 178 | 0 | 46 |
| 2011 | 3 | 187 | 0 | 98 |
| 2012 | 0 | — | 2 | 104 |
| 2013 | 3 | 266 | 0 | 53 |
| 2014 | 3 | 169 | 0 | 45 |
| 2015 | 5 | 140 | 0 | 53 |
| 2016 | 1 | — | 0 | 62 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 4 | 267 | 0 | 23 |
| 2019 | 1 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 119 |
| 2021 | 0 | — | 0 | 189 |
| 2022 | 4 | 79 | 3 | 100 |
| 2023 | 0 | — | 0 | 88 |
| 2024 | 3 | 136 | 0 | 125 |
| 2025 | 2 | — | 0 | 95 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Wallace SIS/AI Catheter is intended to be used in artificial insemination procedures intended for insertion of the catheter and introduction of washed spermatozoa into the uterine cavity. The Wallace SIS/Al Catheter is also intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection abnormalities within uterine cavities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061679 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061679: Wallace Artificial 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/K061679
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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