# K884552: Continuous Epidural Anesthesia Kit W/Poly Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Mar 14, 1989 after 134 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: 8 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
4 of 10 devices 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.

## Most influential descendants
- K103658: Flextip Plus Closed Tip Epidural Catherter (2012), 8 descendants of its own
- K122027: Arrow Flexblock Continuous Peripheral Nerve Block Catheter (2012), 2 descendants of its own
- K143581: Arrow Epidural Catheter Kit (2015), 1 descendant of its own
- K140110: Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set (2015), 1 descendant of its own
- K230603: Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) (2023), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2364-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Dec 20, 2019 · Class II · Z-1252-2020: Product lidstock contains the incorrect expiration date for the product
- Dec 20, 2019 · Class II · Z-1244-2020: Product lidstock contains the incorrect expiration date for the product
- Apr 11, 2018 · Class II · Z-2013-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1957-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1961-2018: Product sterility may be compromised due to unsealed packaging.
- Jan 5, 2015 · Class II · Z-1080-2015: The product labeling does not specify the 5 year shelf life of the product.
- Nov 11, 2010 · Not classified · Z-1012-2011: Sterility may be compromised.

Source page: https://510kreport.com/device/K884552
Methodology: https://510kreport.com/methodology