# K191195: PiccGuard

- Pathway: 510(k) (Traditional)
- Applicant: Piccguard, LLC
- Decided: Jan 3, 2020 after 245 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: 7 generations back to K001901 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172899: Vygon PICCs, Vygon USA (2018) Summary page 4.

## Most influential descendants
- K220507: 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large (2022), 0 descendants of its own

## Indications for use
The PICCGuard device is indicated for use as a tamper evident enclosure for the shaft of the catheter and Luer hub with needleless connector attached on medical devices such as PICC lines and other central line catheter ports.

Source page: https://510kreport.com/device/K191195
Methodology: https://510kreport.com/methodology