# K220507: 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: May 23, 2022 after 90 days
- Product code: PZW (Catheter Access Cover, Tamper-Resistant)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191195: PiccGuard, Piccguard, LLC (2020) Summary page 4.

## Indications for use
3M™ Curos™ Tamper-Evident Device: The 3M™ Curos™ Tamper-Evident Device is intended to be used as a tamper-evident cover for vascular access devices for IV access points including needleless connectors and Y-sites on IV tubing. This device provides visual indication to suspect tampering. This is not a tamper-proof device. 3M™ Curos™ Tamper-Evident Device, Large: The 3M™ Curos™ Tamper-Evident Device, Large is intended to be used as a tamper-evident cover on vascular access device needleless connectors including Y-sites on IV tubing, and infusing connections, providing visual indication of attempts to tamper with or remove the device. This device provides visual indication to suspect tampering. This is not a tamper-proof device.

Source page: https://510kreport.com/device/K220507
Methodology: https://510kreport.com/methodology