# K102173: Moldex-Metric Health Care N95 Particulate Respirator and Surgical Mask, Model 1712

- Pathway: 510(k) (Abbreviated)
- Applicant: Moldex/Metric, Inc.
- Decided: Sep 13, 2010 after 42 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061859: Inovel Health Care N95 Particulate Respirators & Surgical Masks, Inovel, LLC (2006) Summary page 1.
- K051182: Inovel Health Care Model N95 Particulate Respirators and Surgical Masks, Inovel, LLC (2005). Our reading of the summary gave K001182, FDA’s number for Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1 (Microlife Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Moldex-Metric Health Care N95 Particulate Respirators and Surgical…”. Summary page 3.

## Indications for use
The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask meets CDC Guidelines for TB Exposure Control within healthcare facilities. This device is 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/K102173
Methodology: https://510kreport.com/methodology