# K121069: 3M Vflex Health Care Particulate Respirator and Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Feb 11, 2013 after 308 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.
3 later devices descend from it; 1 cites it directly.
0 of 5 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 2.

## Most influential descendants
- K172500: Technoweb Surgical Mask (2018), 2 descendants of its own
- K243342: KP Protective Face Mask (2025), 0 descendants of its own
- K223270: POSE™ Health Care Surgical Mask (2022), 0 descendants of its own

## Indications for use
3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1805/1805S is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K121069
Methodology: https://510kreport.com/methodology