# K061859: Inovel Health Care N95 Particulate Respirators & Surgical Masks

- Pathway: 510(k) (Abbreviated)
- Applicant: Inovel, LLC
- Decided: Jul 12, 2006 after 12 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.
3 later devices descend from it; 3 cite it directly.
0 of 8 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) Summary page 1.

## Most influential descendants
- K102173: Moldex-Metric Health Care N95 Particulate Respirator and Surgical Mask, Model 1712 (2010), 0 descendants of its own
- K063747: Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-a (2007), 0 descendants of its own
- K062663: Moldex Health Care N95 Particulate Respirators and Surgical Masks (2006), 0 descendants of its own

## Indications for use
The various models of Inovel 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/K061859
Methodology: https://510kreport.com/methodology