# K801912: Arrow Positive Placement Con/Epidural an

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Sep 16, 1980 after 36 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: 10 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
46 later devices descend from it; 2 cite it directly.
3 of 47 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
- K021567: Stimucath Continuous Nerve Block Set, Product Number AB-05000 (2002), 32 descendants of its own
- K030937: Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK (2003), 29 descendants of its own
- K033018: Stimulong Plus Catheter Set Model, Various (2004), 23 descendants of its own
- K063282: Contiplex Stim Continuous Nerve Block Set (2007), 13 descendants of its own
- K090995: B. Braun Contiplex Continuous Nerve Block Set (2009), 12 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
- Jul 6, 2020 · Class II · Z-2803-2020: 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
- Jan 15, 2020 · Class II · Z-1175-2020: 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-1249-2020: Product lidstock contains the incorrect expiration date for the product
- Dec 20, 2019 · Class II · Z-1246-2020: Product lidstock contains the incorrect expiration date for the product
- Dec 20, 2019 · Class II · Z-1251-2020: Product lidstock contains the incorrect expiration date for the product
- Dec 20, 2019 · Class II · Z-1248-2020: Product lidstock contains the incorrect expiration date for the product
- Dec 20, 2019 · Class II · Z-1245-2020: Product lidstock contains the incorrect expiration date for the product
- Dec 20, 2019 · Class II · Z-1247-2020: Product lidstock contains the incorrect expiration date for the product
- Apr 11, 2018 · Class II · Z-2012-2018: Product sterility may be compromised due to unsealed packaging.

Source page: https://510kreport.com/device/K801912
Methodology: https://510kreport.com/methodology