510(k) · Cleared
ClearedRejoni Intrauterine Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rejoni, Inc. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Dec 16, 2022 as substantially equivalent to K180300 (Cook Incorporated, 2018) after a 91-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Dec 16, 2022
- Review
- 91 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953034 (1995). 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 backK961752 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1996 · Recalled
- 3 generations backK013972 H/S Elliptosphere Catheter Set, Model 61-4005Ackard Laboratories · 2001 · Recalled
- 2 generations backK083594 EZ HSG Catheter.Foamseal CatheterObg Products · 2009
- 1 generation backK180300 Margolin HSG Cannula, Goldstein Sonohysterography CatheterCook Incorporated · 2018
- This deviceK222798 Rejoni Intrauterine CatheterRejoni, Inc. · 2022
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 | K961752 | H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | 1996 | 2 |
| −3 | K013972 | H/S Elliptosphere Catheter Set, Model 61-4005 | Ackard Laboratories | 2001 | 2 |
| −2 | K083594 | EZ HSG Catheter.Foamseal Catheter | Obg Products | 2009 | — |
| −1 | K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | Cook Incorporated | 2018 | — |
| 0 (this device) | K222798 | Rejoni Intrauterine Catheter | Rejoni, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K180300 | Margolin HSG Cannula, Goldstein Sonohysterography CatheterSummary page 4…Class II Product Code: LKF (Cannula, Manipulator/Injector, Uterine) PREDICATE DEVICE: Margolin HSG Cannula; Goldstein Sonohysterography Catheter (K180300) The predicate device has not been subjected to a design-related recall. DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOT… | 2018 |
| * | — | Margolin HSG Cannula Named without a submission number |
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 27 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 5 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. 2022, 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 Rejoni Intrauterine Catheter is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes.
When used for HSG, the Rejoni Intrauterine Catheter can be used for evaluation of tubal patency.
The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222798 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222798: Rejoni Intrauterine Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222798
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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