# K770356: Anesthesia Kit, Epidural, Single Shot

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Mar 1, 1977 after 7 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: 8 (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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 6, 2020 · Class II · Z-2801-2020: The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other co
- Oct 29, 2010 · Not classified · Z-1351-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1352-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1361-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1353-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1343-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1350-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1354-2011: Sterility may be compromised.

Source page: https://510kreport.com/device/K770356
Methodology: https://510kreport.com/methodology