510(k) · Cleared
ClearedSpinaut-E, Spinaut-I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imedicom Co., Ltd. · BSO Catheter, Conduction, Anesthetic
Cleared on Mar 1, 2016 as substantially equivalent to K980734 (Myelotec, Inc., 1998) and 1 other predicate after a 342-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Mar 1, 2016
- Review
- 342 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954584 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK954584 Racz Epidural CatheterMedic Evaluation Devices & Instruments Corp. · 1996 · Recalled
- 1 generation backK980734 Myelotec Video Guided CatheterMyelotec, Inc. · 1998 · Recalled
- This deviceK150789 Spinaut-E, Spinaut-IImedicom Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK241410 EDEN ControlCathJmt Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K241410EDEN ControlCathJmt Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954584 | Racz Epidural Catheter | Medic Evaluation Devices & Instruments Corp. | 1996 | 1 |
| −1 | K980734 | Myelotec Video Guided Catheter | Myelotec, Inc. | 1998 | 2 |
| 0 (this device) | K150789 | Spinaut-E, Spinaut-I | Imedicom Co., Ltd. | 2016 | — |
| +1 | K241410 | EDEN ControlCath | Jmt Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 K241410 EDEN ControlCathscore 9.5 · 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 |
|---|---|---|---|
| * | K980734 | Myelotec Video Guided CatheterSummary page 4…▪ Classification regulation: 21 CFR 868.5120 4. Predicate Device: ▪ Primary Predicate Device: Myelotec Video Guided Catheter by Myelotec, Inc. (K980734) ▪ Reference Predicate Device: EBI TargetCath Fluoro-Guided Steerable Catheter System by EBI, L.P. (K032390)… | 1998 |
| * | K032390 | Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter SystemSummary page 4…Video Guided Catheter by Myelotec, Inc. (K980734) ▪ Reference Predicate Device: EBI TargetCath Fluoro-Guided Steerable Catheter System by EBI, L.P. (K032390) 1 5. Description: SPINAUT-E consists of a flexible cathete… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241410 | EDEN ControlCath | 2025 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 17.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K241410 (Jmt Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K980734.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
SPINAUT-E is used for delivery of drugs that have been indicated for the epidural space.
SPINAUT-I is intended for the percutaneous introduction and placement of an epidural catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150789 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150789: Spinaut-E, Spinaut-I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150789
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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