# K152597: ProteXsure Safety Capsule System

- Pathway: 510(k) (Traditional)
- Applicant: Starcap Medical, LLC ( Dba Prism Medical & Design)
- Decided: Jun 8, 2016 after 271 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ProteXsure Safety Capsule System is intended as a single use needle protection device which covers the end of needles after use to minimize the risk of needle sticks. The device is designed for use with 25 Gauge to 31 Gauge needles. This device should only be used when a biohazard Sharps Container is not readily available.

Source page: https://510kreport.com/device/K152597
Methodology: https://510kreport.com/methodology