510(k) · Cleared
Recalled · Class II · 2014Intrauterine Insemination and Sonohysterography Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ackrad Laboratories · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Apr 9, 1997 as substantially equivalent to K940176 (Ackrad Laboratories, 1996) after a 58-day review. Its family tree reaches back 2 generations to 1984. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 9, 1997
- Review
- 58 days
- Class
- Class II
- Product code
- LKF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K842231 (1984). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK842231 Ackrad Hysterosalpingography SetAckrad Laboratories · 1984
- 1 generation backK940176 Ackrad Iui Set for Intrauterine InseminationAckrad Laboratories · 1996
- This deviceK970492 Intrauterine Insemination and Sonohysterography CatheterAckrad Laboratories · 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
Most influential descendants
Showing 4 of 4 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842231 | Ackrad Hysterosalpingography Set | Ackrad Laboratories | 1984 | — |
| −1 | K940176 | Ackrad Iui Set for Intrauterine Insemination | Ackrad Laboratories | 1996 | — |
| 0 (this device) | K970492 | Intrauterine Insemination and Sonohysterography Catheter | Ackrad Laboratories | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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 |
|---|---|---|---|
| * | K940176 | Ackrad Iui Set for Intrauterine InseminationSummary page 1…95, Contact person: Bernard Ackerman, Ph.D. Date: February 3, 1997 Device name Tampa Hysterosonography Set Predicate Devices a. Ackrad Intrauterine Insemination Set, K940176/A b. "Goldstein" Sonohysterography Catheter. Description of the device (see exhibit 2) The Tampa Hysterosonography set will con… | 1996 |
| * | — | Goldstein Sonohysterography Catheter Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061679 | Wallace Artificial Insemination Catheter | 2006 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2014 | Class II | Z-1782-2014 | Process control | Sterility of the device may be compromised due to unsealed pouch |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 11.6 years on median.
- None of the 2 ancestors has a recall.
- 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 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?
Injection of saline in the examination of the uterus using ultrasound techniques.
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/K970492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970492: Intrauterine Insemination and Sonohysterography Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970492
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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