# K820009: Arrow Jugular Puncture Kit 16 GA.

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Jan 22, 1982 after 17 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 11 (1 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.
1 of 1 device in its family (counting itself) has 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
- Apr 21, 2026 · Class I · Z-2377-2026: 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-1243-2020: Product lidstock contains the incorrect expiration date for the product
- Apr 11, 2018 · Class II · Z-1974-2018: Product sterility may be compromised due to unsealed packaging.
- Dec 22, 2017 · Class II · Z-1331-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- May 9, 2017 · Class II · Z-2328-2017: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- Oct 29, 2010 · Not classified · Z-1347-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1349-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1344-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1345-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1348-2011: Sterility may be compromised.
- Feb 11, 2009 · Not classified · Z-1494-2009: Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

Source page: https://510kreport.com/device/K820009
Methodology: https://510kreport.com/methodology