# K070139: Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095

- Pathway: 510(k) (Abbreviated)
- Applicant: Survivair, Inc.
- Decided: Mar 2, 2007 after 45 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: 4 generations back to K922507 (1992). 4 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K051182: Inovel Health Care Model N95 Particulate Respirators and Surgical Masks, Inovel, LLC (2005)
- K041855: Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S, Aearo Co. (2004) Summary page 1.

## Most influential descendants
- K070782: Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models HC-NB095F and HC-NB295F (2007), 3 descendants of its own
- K081923: Actiprotect UF N95 Respirator, Double Strap, Flat Fold (2009), 2 descendants of its own
- K141876: Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator (2015), 0 descendants of its own
- K093189: Actiprotect UC N95 Respirator (2010), 0 descendants of its own
- K093161: Actiprotect UF N95 Respirator (2010), 0 descendants of its own

## Indications for use
The Willson® ONE-FitTM HC-NB095 Healthcare Particulate Respirator and Surgical Mask is a NIOSH-approved N95 single use respirator intended for use by healthcare personnel during medical/surgical procedures to protect both the wearer and the patient by protecting the wearer against the spatter of blood and other potentially infectious materials and reducing the transfer of microorganisms and other airborne particulate matter. The Willson ONE-Fit also meets the CDC guidelines for TB exposure control within healthcare facilities and is intended for use as an isolation mask.

Source page: https://510kreport.com/device/K070139
Methodology: https://510kreport.com/methodology