# K945484: Pidural Steroid System

- Pathway: 510(k) (Traditional)
- Applicant: Professional Medical Device Consultants
- Decided: Jun 2, 1995 after 206 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: 31 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Oct 28, 2013 · Class II · Z-0533-2014: 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 indicati
- Jun 7, 2012 · Class III · Z-1943-2012: 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: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2080-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2105-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2079-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2099-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2089-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2103-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2081-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2101-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2100-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2096-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2092-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2097-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2093-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2095-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2086-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2108-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2083-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2088-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2107-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2098-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2102-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2085-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2082-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2104-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2091-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2090-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2087-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2106-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.

Source page: https://510kreport.com/device/K945484
Methodology: https://510kreport.com/methodology