# K140110: Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex, Inc.
- Decided: Mar 27, 2015 after 436 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K884552 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103658: Flextip Plus Closed Tip Epidural Catherter, Teleflex, Inc. (2012) Summary page 5.

## Most influential descendants
- K181782: Medline Reinforced Epidural Catheter (2019), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2371-2026: 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
- Mar 11, 2026 · Class II · Z-1913-2026: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- May 8, 2020 · Class II · Z-2288-2020: Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
- Jan 15, 2020 · Class II · Z-1174-2020: 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.
- Jan 15, 2020 · Class II · Z-1177-2020: 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.
- Jan 15, 2020 · Class II · Z-1172-2020: 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.
- Dec 20, 2019 · Class II · Z-1237-2020: Product lidstock contains the incorrect expiration date for the product
- Dec 20, 2019 · Class II · Z-1238-2020: Product lidstock contains the incorrect expiration date for the product
- Dec 20, 2019 · Class II · Z-1236-2020: Product lidstock contains the incorrect expiration date for the product

## 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/K140110
Methodology: https://510kreport.com/methodology