# K041153: Sharpsaway II Locking Disposable Cup

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Jul 12, 2004 after 70 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K946289 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946289: Devons Point Lok Needle Protection Device, Devon Industries, Inc. (1995) Summary page 1.

## Most influential descendants
- K070577: ON the GO Sharps (2007), 1 descendant of its own
- K081821: D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip) (2008), 0 descendants of its own

## Indications for use
The Arrow SharpsAway IITM Locking Disposal Cup is intended as a single use needle protection device, which covers the end of needles after use to minimize the risk of needle sticks. This device is designed for use with 15 Ga. to 30 Ga. needles for various clinical procedures.

Source page: https://510kreport.com/device/K041153
Methodology: https://510kreport.com/methodology