# K062665: Inovel Health Care N95 Particulate Respirators and Surgical Masks

- Pathway: 510(k) (Traditional)
- Applicant: Inovel, LLC
- Decided: Oct 24, 2006 after 47 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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
- 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

## 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/K062665
Methodology: https://510kreport.com/methodology