510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063013Substantially Equivalent

Pleats Plus N95 Respirator, Models 1054 and 1054S

Aearo Company, Southbridge MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063013 is the FDA 510(k) clearance record for PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S, a class II device, cleared for Aearo Company 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 4 510(k) clearances for Aearo Company, from to . As of , FDA records show no recalls naming K063013.

Clearance record

Decision date
Received
(60 days to decision)
Product code
MSH Respirator, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Aearo Company 90 Mechanic St., Southbridge MA
510(k) summary
Summary PDF
Third party review
No

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