510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083176Substantially Equivalent

Pasture, Models: F550, A520

Pasture Pharma Pte Ltd, Murrieta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083176 is the FDA 510(k) clearance record for PASTURE, MODELS: F550, A520, a class II device, cleared for Pasture Pharma Pte, Ltd. on under FDA product code NZJ (Respirator, N95, For Use By The General Public In Public Health Medical Emergencies). FDA's definition for product code NZJ reads: "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...". FDA records list 3 510(k) clearances for Pasture Pharma Pte, Ltd., from to . As of , FDA records show no recalls naming K083176.

Clearance record

Decision date
Received
(87 days to decision)
Product code
NZJ Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Regulation
21 CFR 880.6260
Device class
Class II
Review panel
General Hospital
Applicant
Pasture Pharma Pte, Ltd. 29266 Via Frontera, Murrieta CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NZJ

Trailing 12 months

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

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