# K070782: Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models HC-NB095F and HC-NB295F

- Pathway: 510(k) (Abbreviated)
- Applicant: Survivair Respirators, LLC
- Decided: Apr 11, 2007 after 21 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: 5 generations back to K922507 (1992). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070139: Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095, Survivair, Inc. (2007) Summary page 1.

## Most influential descendants
- K081923: Actiprotect UF N95 Respirator, Double Strap, Flat Fold (2009), 2 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-Fit™ Flat-Fold™ Healthcare Particulate Respirator and Surgical Masks (HC-NB095F & HC-NB295F) are NIOSH-approved N95 single use respirators 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 Flat-Fold masks also meet the CDC guidelines for TB exposure control within healthcare facilities and are intended for use as an isolation mask.

Source page: https://510kreport.com/device/K070782
Methodology: https://510kreport.com/methodology