510(k) · Cleared
Recalled · Class II · 2019Versa-Kath Epidural Catheter, Model 156-2124
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epimed International, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Aug 15, 2003 as substantially equivalent to K954584 (Medic Evaluation Devices & Instruments Corp., 1996) after a 329-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 15, 2003
- Review
- 329 days
- Class
- Class II
- Product code
- BSO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954584 (1996). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954584 Racz Epidural CatheterMedic Evaluation Devices & Instruments Corp. · 1996 · Recalled
- This deviceK023140 Versa-Kath Epidural Catheter, Model 156-2124Epimed International, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK043500 Functional Anaesthetic Discography (Fad) System, Including Fad…Innospine, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK061210 Functional Anaesthetic Discography (Fad) Catheter System, Model D01A…Kyphon, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK063071 Discyphor Catheter System, Model D01A; Discyphor Introducer Needle…Kyphon, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK073516 Discyphor Direct Catheter System, Discyphor Direct Needles, Long…Kyphon, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK050557 Amt NanocathAmerican Medical Technologies, Inc. · 2005
Most influential descendants
Showing 5 of 5 · See all- K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…Innospine, Inc. · 2005 · cites it directly3descendants
- K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…Kyphon, Inc. · 2006 · 2 generations on2descendants
- K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc. · 2007 · 2 generations on1descendant
- K073516Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…Kyphon, Inc. · 2008 · 2 generations on0descendants
- K050557Amt NanocathAmerican Medical Technologies, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954584 | Racz Epidural Catheter | Medic Evaluation Devices & Instruments Corp. | 1996 | 1 |
| 0 (this device) | K023140 | Versa-Kath Epidural Catheter, Model 156-2124 | Epimed International, Inc. | 2003 | — |
| +1 | K043500 | Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit… | Innospine, Inc. | 2005 | 1 |
| +2 | K061210 | Functional Anaesthetic Discography (Fad) Catheter System, Model D01A… | Kyphon, Inc. | 2006 | — |
| +2 | K063071 | Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B | Kyphon, Inc. | 2007 | — |
| +2 | K073516 | Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor… | Kyphon, Inc. | 2008 | — |
| +1 | K050557 | Amt Nanocath | American Medical Technologies, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 9.4 · 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? (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 |
|---|---|---|---|
| * | K954584 | Racz Epidural CatheterSummary page 1…Epidural Catheter Common Name: Anesthesia Conduction Catheter Product ClassKlassification: Class I1 73 BSO Predicate Devicds): Racz Epidural Catheter (K954584) Description: The Versa-Kath Epidural Catheter consists of a stainless steel spring lumen with a dual coating. The in… | 1996 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2019 | Class II | Z-2069-2019 | Labeling mix-ups | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included. |
| Jun 18, 2019 | Class II | Z-2068-2019 | Labeling mix-ups | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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) | — |
What is it indicated for?
For administration of anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023140: Versa-Kath Epidural Catheter, Model 156-2124.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023140
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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