510(k) · Decided
Recalled · Class II · 2013Pidural Steroid System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Professional Medical Device Consultants · CAZ Anesthesia Conduction Kit
Cleared on Jun 2, 1995 after a 206-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 31 times.
- Decided
- Jun 2, 1995
- Review
- 206 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- 31
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2013 | Class II | Z-0533-2014 | Component design/selection | Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may… |
| Jun 7, 2012 | Class III | Z-1943-2012 | Packaging process control | Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components. |
| Jul 13, 2009 | Not classified | Z-2094-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2080-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2105-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2079-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2099-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2089-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2103-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2081-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2101-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2100-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2096-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2092-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2097-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2093-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2095-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2086-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2108-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2083-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2088-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2107-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2098-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2102-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2085-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2082-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2104-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2091-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2090-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2087-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2106-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
The 5 latest of 31 recalls; the web page lists all.
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) | — |
https://510kreport.com/device/K945484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945484: Pidural Steroid System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945484
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026