# K020921: NO-Pokes Needle Safety Device

- Pathway: 510(k) (Traditional)
- Applicant: Bemis Mfg. Co.
- Decided: Jul 11, 2002 after 112 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
NO-POKESm is a disposable needle recapping aid that helps prevent recapping injury by providing repository for the needle cap (other than the user's hand) in which to place the cap while using the syringe. This keeps the user's hand away from the needle during uncapping and recapping. The cap of the capped needle is placed in the NO-POKESTM. The "wax-like" substance in the NO-POKESTM holds the cap securely while the operator uses the needle. After the procedure, while the cap is secured in the NO-POKESTM, the operator inserts the needle back into the cap without exposing hislher hand to the needle. The NO-POKESm container has an adhesive on the base to hold it to the desired surface while in use.

Source page: https://510kreport.com/device/K020921
Methodology: https://510kreport.com/methodology