# K171116: 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Aug 10, 2017 after 118 days
- Product code: MSH (Respirator, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063023 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063023: 3M Health Care Particulate Respirator and Surgical Mask, Model 1870, 3M Company (2007) Summary page 4.

## Indications for use
3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1804/1804S is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K171116
Methodology: https://510kreport.com/methodology