510(k) · Cleared
ClearedCombined End-Multiple Lateral Holes Epidural Catheter (Cemlh Epidural Catheter)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Csen, Ltd. · BSO Catheter, Conduction, Anesthetic
Cleared on May 30, 1997 after a 767-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- May 30, 1997
- Review
- 767 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK951927 Combined End-Multiple Lateral Holes Epidural Catheter (Cemlh…Csen, Ltd. · 1997
- Descendant · cites it directly · 9 of its ownK042488 Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK043500 Functional Anaesthetic Discography (Fad) System, Including Fad…Innospine, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 2 of its ownK061210 Functional Anaesthetic Discography (Fad) Catheter System, Model D01A…Kyphon, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK063071 Discyphor Catheter System, Model D01A; Discyphor Introducer Needle…Kyphon, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK153297 Perifix and Contiplex CatheterB.Braun Medical, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K042488Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004 · cites it directly9descendants
- K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…Innospine, Inc. · 2005 · 2 generations on3descendants
- K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…Kyphon, Inc. · 2006 · 3 generations on2descendants
- K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc. · 2007 · 3 generations on1descendant
- K153297Perifix and Contiplex CatheterB.Braun Medical, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951927 | Combined End-Multiple Lateral Holes Epidural Catheter (Cemlh Epidural Catheter) | Csen, Ltd. | 1997 | — |
| +1 | K042488 | Perifix Catheter and Contiplex Catheter | B.Braun Medical, Inc. | 2004 | — |
| +2 | K043500 | Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit… | Innospine, Inc. | 2005 | 1 |
| +3 | K061210 | Functional Anaesthetic Discography (Fad) Catheter System, Model D01A… | Kyphon, Inc. | 2006 | — |
| +3 | K063071 | Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B | Kyphon, Inc. | 2007 | — |
| +2 | K153297 | Perifix and Contiplex Catheter | B.Braun Medical, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 9.4 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042488 | Perifix Catheter and Contiplex Catheter | 2004 | 9 |
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?
- Of its descendants, K042488 (B.Braun Medical, Inc., 2004) has gone furthest, with 9 descendants of its own.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K951927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951927: Combined End-Multiple Lateral Holes Epidural Catheter (Cemlh Epidural Catheter).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951927
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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