510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120244Substantially Equivalent

Spectrashield 9500 Surgical N95 Respirator

Nexera Medical LLC, Ft.Lauderdale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120244 is the FDA 510(k) clearance record for SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR, a class II device, cleared for Nexera Medical, Inc. on under FDA product code ONT (N95 Respirator With Antimicrobial/Antiviral Agent). FDA's definition for product code ONT reads: "A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or...". FDA records list 3 510(k) clearances for Nexera Medical, Inc., from to . As of , FDA records show no recalls naming K120244.

Clearance record

Decision date
Received
(160 days to decision)
Product code
ONT N95 Respirator With Antimicrobial/Antiviral Agent
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Nexera Medical, Inc. 3343 W. Commercial Blvd., Suite 103, Ft.Lauderdale FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONT

Trailing 12 months

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

FDA records show no clearances under product code ONT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ONT, 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