# K021120: Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP

- Pathway: 510(k) (Special)
- Applicant: Arrow Intl., Inc.
- Decided: May 2, 2002 after 24 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K810675 (1981). 2 ancestors in all.
7 later devices descend from it; 3 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)
- K810675: Arrow Radial Artery Catheterization Set, Arrow Intl., Inc. (1981) Summary page 1.
- K003006: Two-Lumen Picc with Blue Flextip Catheter and Integral Needle Protection, Arrow Intl., Inc. (2000). Our OCR of the scanned summary read K000306, FDA’s number for Pinnacle Acetabular System (DePuy Orthopaedics, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Arrow PICC Two-lumen Peripherally-inserted Central Catheter Kit with…”.

## Most influential descendants
- K151513: Arrow Endurance Extended Dwell Peripheral Catheter System (2015), 4 descendants of its own
- K152272: Arrow Endurance Extended Dwell Peripheral Catheter System (2015), 3 descendants of its own
- K163513: Arrow Endurance Extended Dwell Peripheral Catheter System (2017), 2 descendants of its own
- K243599: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (2025), 0 descendants of its own
- K242281: Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) (2024), 0 descendants of its own

## 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
- Apr 11, 2018 · Class II · Z-1973-2018: Product sterility may be compromised due to unsealed packaging.

## Indications for use
The Arrow arterial catheterization device permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.

Source page: https://510kreport.com/device/K021120
Methodology: https://510kreport.com/methodology