# K133635: Easypoint Needle

- Pathway: 510(k) (Traditional)
- Applicant: Retractable Technologies, Inc.
- Decided: Jun 17, 2014 after 203 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931367 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021475: BD Single Lumen Needle, Syringe and Blood Collection Set, Bd (2002) Summary page 1.
- K970803: Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint Syringe, Retractable Technologies, Inc. (1997) Summary page 1.

## Recalls of this device
- Feb 5, 2024 · Class II · Z-1293-2024: The needle cannula of a retractable needle may detach from the needle holder in the patient.

## Indications for use
The Easy Point Needle is intended for use with syringes for general purpose fluid injections and/or aspiration, and venipuncture to obtain blood collection. The Easy Point Needle aids the prevention of needlestick injuries.

Source page: https://510kreport.com/device/K133635
Methodology: https://510kreport.com/methodology