510(k) · Cleared
ClearedCook Silicone Balloon HSG Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Oct 26, 2018 as substantially equivalent to K160217 (Cook Incorporated, 2016) after a 267-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Oct 26, 2018
- Review
- 267 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953034 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK953034 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1995
- 4 generations backK020951 H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model…Ackrad Laboratories · 2002 · Recalled
- 3 generations backK032835 H/S Catheter SetCatheter Research, Inc. · 2003 · Recalled
- 2 generations backK123258 The Advance Catheter for HSG and SisCatheter Research, Inc. · 2013
- 1 generation backK160217 uVue HSG/SHG CatheterCook Incorporated · 2016
- This deviceK180291 Cook Silicone Balloon HSG CatheterCook Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953034 | H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | 1995 | — |
| −4 | K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007 | Ackrad Laboratories | 2002 | 1 |
| −3 | K032835 | H/S Catheter Set | Catheter Research, Inc. | 2003 | 1 |
| −2 | K123258 | The Advance Catheter for HSG and Sis | Catheter Research, Inc. | 2013 | — |
| −1 | K160217 | uVue HSG/SHG Catheter | Cook Incorporated | 2016 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K160217 | uVue HSG/SHG CatheterSummary page 4…LKF (Cannula, Manipulator/Injector, Uterine) Device Classification: Class II Predicate Device: uVue® HSG/SHG Catheter, Cook Incorporated, K160217 The predicate device has not been subject to any design-related recalls. Device Description: The Cook® Silicone Balloon HSG Cat… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 8 ancestors have a recall of any class.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Cook® Silicone Balloon HSG Catheter is used for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for the evaluation of tubal patency using hysterosalpingography, or to access the uterine cavity for saline infusion sonohysterography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180291: Cook Silicone Balloon HSG Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180291
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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