510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880442Substantially Equivalent

Brushrite

Pro Care Laboratories, Inc., West Point NE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880442 is the FDA 510(k) clearance record for BRUSHRITE, a class II device, cleared for Pro Care Laboratories, Inc. on under FDA product code JEG (Analyzer, Gas, Argon, Gaseous-Phase). FDA records list one 510(k) clearance for Pro Care Laboratories, Inc. As of , FDA records show no recalls naming K880442.

Clearance record

Decision date
Received
(104 days to decision)
Product code
JEG Analyzer, Gas, Argon, Gaseous-Phase
Regulation
21 CFR 868.1075
Device class
Class II
Review panel
Anesthesiology
Applicant
Pro Care Laboratories, Inc. 218 W. Park St., West Point NE
Third party review
No

Clearances, product code JEG

Trailing 12 months

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

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