# K052725: Protector Needle Sheath Prop

- Pathway: 510(k) (Traditional)
- Applicant: Certol International, LLC
- Decided: Dec 28, 2005 after 90 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. The FDA summary names its predicate without a number.
- (no number) Bull's Eye Disposable Needle Recapping Aid: named in the summary without a submission number

## Indications for use
ProTector TM Needle Sheath Prop is a disposable, non-sterile device that can be used to safely uncap and recap needles using a one-handed technique. ProTectorTM Needle Sheath Prop facilitates OSHA requirements by reducing the possibility of accidental needle sticks and discourages leaving the needle unsheathed on the tray. The Prop is autoclavable for one-time sterile tray set-up. It holds the cap securely in the ready position.

Source page: https://510kreport.com/device/K052725
Methodology: https://510kreport.com/methodology