510(k) · Cleared
Recalled · Class II · 2021Racz Epidural Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medic Evaluation Devices & Instruments Corp. · BSO Catheter, Conduction, Anesthetic
Cleared on Oct 8, 1996 after a 372-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it. It has been recalled once.
- Decided
- Oct 8, 1996
- Review
- 372 days
- Class
- Class II
- Product code
- BSO
- Recalls
- 1
- Predicates
- 0
12 later devices descend from it, 4 citing it directly.
- This deviceK954584 Racz Epidural CatheterMedic Evaluation Devices & Instruments Corp. · 1996
- Descendant · cites it directly · 5 of its ownK023140 Versa-Kath Epidural Catheter, Model 156-2124Epimed International, Inc. · 2003 · Recalled
- Descendant · cites it directly · 4 of its ownK980734 Myelotec Video Guided CatheterMyelotec, Inc. · 1998 · Recalled
- 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 · 2 generations on · 1 of its ownK150789 Spinaut-E, Spinaut-IImedicom Co., Ltd. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K023140Versa-Kath Epidural Catheter, Model 156-2124Epimed International, Inc. · 2003 · cites it directly5descendants
- K980734Myelotec Video Guided CatheterMyelotec, Inc. · 1998 · cites it directly4descendants
- 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
- K150789Spinaut-E, Spinaut-IImedicom Co., Ltd. · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954584 | Racz Epidural Catheter | Medic Evaluation Devices & Instruments Corp. | 1996 | — |
| +1 | K023140 | Versa-Kath Epidural Catheter, Model 156-2124 | Epimed International, Inc. | 2003 | 2 |
| +1 | K980734 | Myelotec Video Guided Catheter | Myelotec, Inc. | 1998 | 2 |
| +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 | — |
| +2 | K150789 | Spinaut-E, Spinaut-I | Imedicom Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 124 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 |
|---|---|---|---|---|
| Feb 1, 2021 | Class II | Z-1276-2021 | Process control | Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023140 (Epimed International, Inc., 2003) has gone furthest, with 5 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/K954584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954584: Racz 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/K954584
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026