510(k) · Cleared
ClearedEDEN ControlCath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jmt Co., Ltd. · BSO Catheter, Conduction, Anesthetic
Cleared on Feb 13, 2025 as substantially equivalent to K150789 (Imedicom Co., Ltd., 2016) after a 272-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Feb 13, 2025
- Review
- 272 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954584 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK954584 Racz Epidural CatheterMedic Evaluation Devices & Instruments Corp. · 1996 · Recalled
- 2 generations backK980734 Myelotec Video Guided CatheterMyelotec, Inc. · 1998 · Recalled
- 1 generation backK150789 Spinaut-E, Spinaut-IImedicom Co., Ltd. · 2016
- This deviceK241410 EDEN ControlCathJmt Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954584 | Racz Epidural Catheter | Medic Evaluation Devices & Instruments Corp. | 1996 | 1 |
| −2 | K980734 | Myelotec Video Guided Catheter | Myelotec, Inc. | 1998 | 2 |
| −1 | K150789 | Spinaut-E, Spinaut-I | Imedicom Co., Ltd. | 2016 | — |
| 0 (this device) | K241410 | EDEN ControlCath | Jmt Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 BSO? 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 BSO device
- #1 K231242 Perifix FX Catheter; Contiplex FX Catheterscore 7.8 · 7 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 |
|---|---|---|---|
| * | K150789 | Spinaut-E, Spinaut-ISummary page 5…Product Code BSO 3. Predicated or legally marketed devices which are substantially equivalent Predicated device: K150789, “SPINAUT-E, SPINAUT-I”, manufactured by “IMEDICOM Co., Ltd.” 4. Device Description EDEN ControlCath consists o… | 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 29 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · BSO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSO
205in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSO
2so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSO
139in 2025
MAUDE reports naming product code BSO, 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 | 2 | — | 0 | 18 |
| 2008 | 3 | 155 | 0 | 14 |
| 2009 | 1 | — | 1 | 71 |
| 2010 | 1 | — | 0 | 57 |
| 2011 | 4 | 109 | 0 | 31 |
| 2012 | 0 | — | 0 | 52 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 2 | — | 0 | 45 |
| 2015 | 1 | — | 0 | 43 |
| 2016 | 5 | 281 | 0 | 71 |
| 2017 | 3 | 205 | 0 | 38 |
| 2018 | 2 | — | 0 | 80 |
| 2019 | 2 | — | 0 | 779 |
| 2020 | 2 | — | 0 | 159 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 0 | — | 0 | 135 |
| 2023 | 2 | — | 0 | 79 |
| 2024 | 0 | — | 0 | 98 |
| 2025 | 1 | — | 0 | 139 |
| 2026 | 0 | — | 2 (1) | — |
What is it indicated for?
EDEN ControlCath is used for delivery of drugs that have been indicated for the epidural space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241410: EDEN ControlCath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241410
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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