510(k) · Cleared
ClearedEZ HSG Catheter.Foamseal Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Obg Products · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Jul 21, 2009 as substantially equivalent to K013972 (Ackard Laboratories, 2001) after a 228-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Jul 21, 2009
- Review
- 228 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953034 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK953034 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1995
- 2 generations backK961752 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1996 · Recalled
- 1 generation backK013972 H/S Elliptosphere Catheter Set, Model 61-4005Ackard Laboratories · 2001 · Recalled
- This deviceK083594 EZ HSG Catheter.Foamseal CatheterObg Products · 2009
- Descendant · cites it directly · 1 of its ownK180300 Margolin HSG Cannula, Goldstein Sonohysterography CatheterCook Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK222798 Rejoni Intrauterine CatheterRejoni, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView 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 | K961752 | H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | 1996 | 2 |
| −1 | K013972 | H/S Elliptosphere Catheter Set, Model 61-4005 | Ackard Laboratories | 2001 | 2 |
| 0 (this device) | K083594 | EZ HSG Catheter.Foamseal Catheter | Obg Products | 2009 | — |
| +1 | K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | Cook Incorporated | 2018 | — |
| +2 | K222798 | Rejoni Intrauterine Catheter | Rejoni, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K013972 | H/S Elliptosphere Catheter Set, Model 61-4005Summary page 2…Page 1 Predicate Device: This Foam Seal catheter is comparable to existing predicate devices: H/S Flliptosphere Catheter set with 510K number K 013972. Intended Use: The Foam Seal SII-ISG Catheter is intended for introduction of liquid into the uterine cavity for ultrasonogram… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | 2018 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K180300 (Cook Incorporated, 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K013972.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Injection of fluid into the uterine cavity during Saline Infusion sonogram (SIS) & hysterosalpinogram (HSG), Following are some Clinical Indications:
1. Infertility.
2. Menorrahagia.
3. Dysmenorrhea.
4. Suspected Endometrial Polyp.
5. Uterine Fibroid.
6. Amenorrhea due to Uterine Synechea (Asherman Syndrome).
7. Congenital Uterine Anomaly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083594: EZ HSG Catheter.Foamseal Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083594
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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