510(k) · Cleared
Recalled · Class II · 2015H/S Catheter Set
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 Dec 11, 2003 as substantially equivalent to K020292 (Catheter Research, Inc., 2002) and 2 other predicates after a 91-day review. Its family tree reaches back 2 generations to 1995. 7 later devices descend from it. It has been recalled once.
- Decided
- Dec 11, 2003
- Review
- 91 days
- Class
- Class II
- Product code
- LKF
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953034 (1995). 4 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953034 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1995
- 1 generation backK020951 H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model…Ackrad Laboratories · 2002 · Recalled
- This deviceK032835 H/S Catheter SetCatheter Research, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK123258 The Advance Catheter for HSG and SisCatheter Research, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK092579 Intrauterine Insemination (Iui) CatheterFertiligent, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK160217 uVue HSG/SHG CatheterCook Incorporated · 2016
- Descendant · 2 generations on · 0 of its ownK181770 Intrauterine Access Balloon Catheter, Selective Salpingography…Cook Incorporated · 2019
- Descendant · 3 generations on · 0 of its ownK180291 Cook Silicone Balloon HSG CatheterCook Incorporated · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K123258The Advance Catheter for HSG and SisCatheter Research, Inc. · 2013 · cites it directly3descendants
- K092579Intrauterine Insemination (Iui) CatheterFertiligent, Ltd. · 2010 · cites it directly2descendants
- K160217uVue HSG/SHG CatheterCook Incorporated · 2016 · 2 generations on1descendant
- K181770Intrauterine Access Balloon Catheter, Selective Salpingography CatheterCook Incorporated · 2019 · 2 generations on0descendants
- K180291Cook Silicone Balloon HSG CatheterCook Incorporated · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953034 | H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | 1995 | — |
| −1 | K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007 | Ackrad Laboratories | 2002 | 1 |
| 0 (this device) | K032835 | H/S Catheter Set | Catheter Research, Inc. | 2003 | — |
| +1 | K123258 | The Advance Catheter for HSG and Sis | Catheter Research, Inc. | 2013 | — |
| +1 | K092579 | Intrauterine Insemination (Iui) Catheter | Fertiligent, Ltd. | 2010 | — |
| +2 | K160217 | uVue HSG/SHG Catheter | Cook Incorporated | 2016 | — |
| +2 | K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | Cook Incorporated | 2019 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K020292 | Uterine InjectorSummary page 1…on Name: Cannula, manipulator/injector, uterine Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Uterine Injector (Catheter Research, Inc.) K020292 H/S Catheters (Ackrad Laboratories) K020951 & K020951 Uterine Injector (Thomas Medical, Inc.) K022503 D… | 2002 |
| * | K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007Summary page 1…Marketed Devices To Which Substantial Equivalence Is Claimed: Uterine Injector (Catheter Research, Inc.) K020292 H/S Catheters (Ackrad Laboratories) K020951 & K020951 Uterine Injector (Thomas Medical, Inc.) K022503 Device Description: The HS Catheter devices consist of a pl… | 2002 |
| * | K022503 | Uterine InjectorSummary page 1…Uterine Injector (Catheter Research, Inc.) K020292 H/S Catheters (Ackrad Laboratories) K020951 & K020951 Uterine Injector (Thomas Medical, Inc.) K022503 Device Description: The HS Catheter devices consist of a plastic tube, the distal end of which has an inflatable cuff. A sheat… | 2002 |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2015 | Class II | Z-1481-2015 | Packaging process control | HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K123258 (Catheter Research, Inc., 2013) 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?
The intended use of the HS Catheter is for the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes. The intended use of the SHG Catheter is for the delivery of saline into the female reproductive tract for examination of the uterus and fallopian tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032835: H/S 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/K032835
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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