Cleared Traditional

K120244 - SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120244 · Nexera Medical, Inc. · General Hospital
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Jul 2012
Decision
160d
Days
Class 2
Risk

K120244 is an FDA 510(k) clearance for the SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR. Classified as N95 Respirator With Antimicrobial/antiviral Agent (product code ONT), Class II - Special Controls.

Submitted by Nexera Medical, Inc. (Ft.Lauderdale, US). The FDA issued a Cleared decision on July 5, 2012 after a review of 160 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Nexera Medical, Inc. devices

Submission Details

510(k) Number K120244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2012
Decision Date July 05, 2012
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 128d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONT N95 Respirator With Antimicrobial/antiviral Agent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
Definition 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 Antiviral Agent Which Kills Specified Pathogens Under Specified Contact Conditions.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.