510(k) · Cleared
Recalled · Class II · 2022H/S Elliptosphere Catheter Set, Model 61-4005
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ackard Laboratories · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Dec 17, 2001 as substantially equivalent to K961752 (Ackrad Laboratories, 1996) after a 14-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 17, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- LKF
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953034 (1995). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK953034 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1995
- 1 generation backK961752 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1996 · Recalled
- This deviceK013972 H/S Elliptosphere Catheter Set, Model 61-4005Ackard Laboratories · 2001
- Descendant · cites it directly · 2 of its ownK083594 EZ HSG Catheter.Foamseal CatheterObg Products · 2009
- Descendant · 2 generations on · 1 of its ownK180300 Margolin HSG Cannula, Goldstein Sonohysterography CatheterCook Incorporated · 2018
- Descendant · 3 generations on · 0 of its ownK222798 Rejoni Intrauterine CatheterRejoni, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK063611 Saline/ Contrast Media Infusion CatheterUtah Medical Products, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK021272 Sib Catheter, Model 61-7005Ackrad Laboratories · 2002
Most influential descendants
Showing 5 of 5 · See all- K083594EZ HSG Catheter.Foamseal CatheterObg Products · 2009 · cites it directly2descendants
- K180300Margolin HSG Cannula, Goldstein Sonohysterography CatheterCook Incorporated · 2018 · 2 generations on1descendant
- K222798Rejoni Intrauterine CatheterRejoni, Inc. · 2022 · 3 generations on0descendants
- K063611Saline/ Contrast Media Infusion CatheterUtah Medical Products, Inc. · 2007 · cites it directly0descendants
- K021272Sib Catheter, Model 61-7005Ackrad Laboratories · 2002 · cites it directly0descendants
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 | K961752 | H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | 1996 | 2 |
| 0 (this device) | K013972 | H/S Elliptosphere Catheter Set, Model 61-4005 | Ackard Laboratories | 2001 | — |
| +1 | K083594 | EZ HSG Catheter.Foamseal Catheter | Obg Products | 2009 | — |
| +2 | K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | Cook Incorporated | 2018 | — |
| +3 | K222798 | Rejoni Intrauterine Catheter | Rejoni, Inc. | 2022 | — |
| +1 | K063611 | Saline/ Contrast Media Infusion Catheter | Utah Medical Products, Inc. | 2007 | — |
| +1 | K021272 | Sib Catheter, Model 61-7005 | Ackrad Laboratories | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K961752 | H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Summary page 1…Hysterosonography Catheter Classification Name: Cannula, manipulator/injector, Uterine, Product Code LKF Modified Hysterosalpingography Set with Polyurethane Balloon K961752, 8/19/96 November 26, 2001 Richard Hettenbach Vice President, Regulatory Affairs and Quality Assurance Ackrad Laboratories, In… | 1996 |
What descends from it? (5)
3 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 |
|---|---|---|---|---|
| Mar 31, 2022 | Class II | Z-0503-2024 | Component design/selection | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure |
| Mar 31, 2022 | Class II | Z-0504-2024 | Component design/selection | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K083594 (Obg Products, 2009) has gone furthest, with 2 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 H/S Elliptosphere Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.
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/K013972 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013972: H/S Elliptosphere Catheter Set, Model 61-4005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013972
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026