# K103658: Flextip Plus Closed Tip Epidural Catherter

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex, Inc.
- Decided: May 16, 2012 after 518 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884552 (1989). 1 ancestor in all.
8 later devices descend from it; 4 cite 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)
- K884552: Continuous Epidural Anesthesia Kit W/Poly Catheter, Arrow Intl., Inc. (1989) Summary page 1.

## Most influential descendants
- 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
- K181782: Medline Reinforced Epidural Catheter (2019), 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
- Jan 15, 2020 · Class II · Z-1179-2020: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
- Apr 11, 2018 · Class II · Z-1962-2018: Product sterility may be compromised due to unsealed packaging.
- Jul 30, 2015 · Class II · Z-2462-2015: the catheter peel-away component hub tabs may prematurely detach. One injury reported.

## Indications for use
The Arrow Epidural Catheter permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.

Source page: https://510kreport.com/device/K103658
Methodology: https://510kreport.com/methodology