510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062665Substantially Equivalent

Inovel Health Care N95 Particulate Respirators and Surgical Masks

Moldex/Metric, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062665 is the FDA 510(k) clearance record for INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, a class II device, cleared for Inovel, LLC on under FDA product code MSH (Respirator, Surgical). FDA's definition for product code MSH reads: "A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific...". FDA records list 7 510(k) clearances for MOLDEX/METRIC, INC., from to . As of , FDA records show no recalls naming K062665.

Clearance record

Decision date
Received
(47 days to decision)
Product code
MSH Respirator, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Inovel, LLC 10111 W. Jefferson Blvd., Culver City CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code MSH

Trailing 12 months

FDA records hold no clearances under product code MSH in the trailing twelve months.

FDA records show no clearances under product code MSH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MSH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260