510(k) · Decided
DecidedEpistar/Epistar Cse Spinal/Epidural Anesthesia Administration Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimex Holfeld GmbH & Co. · CAZ Anesthesia Conduction Kit
Cleared on Aug 18, 1999 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 18, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 CAZ? 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 CAZ device
- #1 K261372 Profoject™ LOR Syringescore 12.4 · 2 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?
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.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CAZ
108in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAZ
1in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · CAZ
137in 2025
MAUDE reports naming product code CAZ, 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 | 4 | 172 | 0 | 81 |
| 2008 | 4 | 99 | 0 | 80 |
| 2009 | 2 | — | 29 | 134 |
| 2010 | 2 | — | 8 | 139 |
| 2011 | 1 | — | 2 | 187 |
| 2012 | 9 | 108 | 0 | 187 |
| 2013 | 0 | — | 12 | 276 |
| 2014 | 0 | — | 2 | 251 |
| 2015 | 1 | — | 1 | 235 |
| 2016 | 2 | — | 1 | 372 |
| 2017 | 0 | — | 0 | 353 |
| 2018 | 0 | — | 0 | 448 |
| 2019 | 1 | — | 0 | 472 |
| 2020 | 1 | — | 0 | 274 |
| 2021 | 1 | — | 0 | 165 |
| 2022 | 1 | — | 0 | 270 |
| 2023 | 1 | — | 0 | 60 |
| 2024 | 0 | — | 1 | 165 |
| 2025 | 0 | — | 0 | 137 |
| 2026 | 1 | — | 12 (11) | — |
What is it indicated for?
The MEDIMEX Epistar CSE kit is intended for administration of epidural anesthesia that may be combined with a spinal anesthetic. The MEDIMEX CSE epidural needle in the Epistar CSE kit I is intended for single epidural injections for epidural anesthesia, or for introduction of the MEDIMEX catheter in the CSE kit for continuous epidural anesthesia, for cathetcrization duration of up to 72 hours. The CSE epidural necdle is also intended to allow passage of…
Read the full statement (128 words)
The MEDIMEX Epistar CSE kit is intended for administration of epidural anesthesia that may be combined with a spinal anesthetic. The MEDIMEX CSE epidural needle in the Epistar CSE kit I is intended for single epidural injections for epidural anesthesia, or for introduction of the MEDIMEX catheter in the CSE kit for continuous epidural anesthesia, for cathetcrization duration of up to 72 hours. The CSE epidural necdle is also intended to allow passage of a pencil point-spinal needle into the intrathecal space to provide anesthesia immediately before or after placement of the epidyral catheter. The MEDIMEX Epistar epidural kit containing the conventional epistar epidural needle, is intended only to provide epidural anesthesia by single epidural injection or by catheterization of the epidural space for up to 72 hours.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991719: Epistar/Epistar Cse Spinal/Epidural Anesthesia Administration Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991719
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026