510(k) · Cleared
ClearedHSG Catheter Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioteque America, Inc. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Jun 17, 2004 after a 51-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jun 17, 2004
- Review
- 51 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK041094 HSG Catheter SetBioteque America, Inc. · 2004
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K041094 | HSG Catheter Set | Bioteque America, Inc. | 2004 | — |
| +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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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)
No FDA recall names this device.
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 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?
Bioteque's HSG catheter sets are indicated to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurring pregnancy loss, or unexplained infertility. They can also be used to assess uterine pathology and patients on tamoxifan therapy.
HSG type catheter sets are used to infuse a fluid (either a contrast media or a sterile saline) into the uterine cavity while blocking the external cervical OS to retain the fluid in the uterus during the procedure.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041094: HSG Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041094
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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