Cleared Traditional

K083176 - PASTURE, MODELS: F550, A520 (FDA 510(k) Clearance)

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

K083176 · Pasture Pharma Pte, Ltd. · General Hospital
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Jan 2009
Decision
87d
Days
Class 2
Risk

K083176 is an FDA 510(k) clearance for the PASTURE, MODELS: F550, A520. Classified as Respirator, N95, For Use By The General Public In Public Health Medical Emergencies (product code NZJ), Class II - Special Controls.

Submitted by Pasture Pharma Pte, Ltd. (Murrieta, US). The FDA issued a Cleared decision on January 23, 2009 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6260 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pasture Pharma Pte, Ltd. devices

Submission Details

510(k) Number K083176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2008
Decision Date January 23, 2009
Days to Decision 87 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
41d faster than avg
Panel avg: 128d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NZJ Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6260
Definition It Is Intended To Cover The Nose And Mouth Of The Wearer To Help Reduce Wearer Exposure To Pathogenic Biological Airborne Particulates During Public Health Medical Emergencies, Such As Influenza Pandemic And Also Protects The Wearer From Splash And Spray Of Body Fluids.
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.