510(k) · Cleared
ClearedThe Advance Catheter for HSG and Sis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catheter Research, Inc. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Jan 31, 2013 as substantially equivalent to K032835 (Catheter Research, Inc., 2003) and 1 other predicate after a 105-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Jan 31, 2013
- Review
- 105 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953034 (1995). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK953034 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1995
- 2 generations backK020951 H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model…Ackrad Laboratories · 2002 · Recalled
- 1 generation backK032835 H/S Catheter SetCatheter Research, Inc. · 2003 · Recalled
- This deviceK123258 The Advance Catheter for HSG and SisCatheter Research, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK160217 uVue HSG/SHG CatheterCook Incorporated · 2016
- Descendant · cites it directly · 0 of its ownK181770 Intrauterine Access Balloon Catheter, Selective Salpingography…Cook Incorporated · 2019
- Descendant · 2 generations on · 0 of its ownK180291 Cook Silicone Balloon HSG CatheterCook Incorporated · 2018
Most influential descendants
Showing 3 of 3 · See all- K160217uVue HSG/SHG CatheterCook Incorporated · 2016 · cites it directly1descendant
- K181770Intrauterine Access Balloon Catheter, Selective Salpingography CatheterCook Incorporated · 2019 · cites it directly0descendants
- K180291Cook Silicone Balloon HSG CatheterCook Incorporated · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953034 | H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | 1995 | — |
| −2 | K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007 | Ackrad Laboratories | 2002 | 1 |
| −1 | K032835 | H/S Catheter Set | Catheter Research, Inc. | 2003 | 1 |
| 0 (this device) | K123258 | The Advance Catheter for HSG and Sis | Catheter Research, Inc. | 2013 | — |
| +1 | K160217 | uVue HSG/SHG Catheter | Cook Incorporated | 2016 | — |
| +1 | K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | Cook Incorporated | 2019 | — |
| +2 | K180291 | Cook Silicone Balloon HSG Catheter | Cook Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 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 |
|---|---|---|---|
| * | K032835 | H/S Catheter SetSummary page 1…Submission Legally Marketed Devices to Which Substantial Equivalence Is Claimed: HS and SHG Catheters K032835 FemVue TM Catheter System K083690 Device Description: The "The Advance Catheter for HSG and SIS (A… | 2003 |
| * | K083690 | Femvue (TM) Catheter SystemSummary page 1…s to Which Substantial Equivalence Is Claimed: HS and SHG Catheters K032835 FemVue TM Catheter System K083690 Device Description: The "The Advance Catheter for HSG and SIS (Advance Catheter) consist of a plastic tube, the distal end of whi… | 2009 |
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 18 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K160217 (Cook Incorporated, 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K032835.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 intended use of "The Advance Catheter for HSG and 515" is for the delivery of contrast media or saline during hysterosalpingogram (HSG) and saline infusion sonohysterography (515) into the female reproductive tract for examination of the uterus andWar fallopian tubes.
The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or selective evaluation of fallopian tube patency.
The Advance Catheter for HSG and 515 will be available in 5F size for patients with a nulliparous cervix and 7F size for patients with a multiparous cervix.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123258: The Advance Catheter for HSG and Sis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123258
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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