# K051182: Inovel Health Care Model N95 Particulate Respirators and Surgical Masks

- Pathway: 510(k) (Abbreviated)
- Applicant: Inovel, LLC
- Decided: May 19, 2005 after 10 days
- Product code: MSH (Respirator, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922507 (1992). 3 ancestors in all.
11 later devices descend from it; 6 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041855: Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S, Aearo Co. (2004) Summary page 1.
- K960778: Isolair Apr Type N95, Louis M. Gerson Co., Inc. (1996) Summary page 1.

## Most influential descendants
- K070139: Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095 (2007), 5 descendants of its own
- K070782: Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models HC-NB095F and HC-NB295F (2007), 3 descendants of its own
- K061859: Inovel Health Care N95 Particulate Respirators & Surgical Masks (2006), 3 descendants of its own
- K081923: Actiprotect UF N95 Respirator, Double Strap, Flat Fold (2009), 2 descendants of its own
- K062665: Inovel Health Care N95 Particulate Respirators and Surgical Masks (2006), 1 descendant of its own

## Recalls of this device
- Feb 20, 2006 · Not classified · Z-0587-06: Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number

## Indications for use
The various models of Inovel/Cardinal Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K051182
Methodology: https://510kreport.com/methodology