510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K030348Substantially Equivalent

Biopure Portable Ro System,biopure 4400 Series Ro System, Biopure 8400 Series Ro System,biopure Water Purfication Pretre

Biolab Equipment Canada, Ltd., Thornhill, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030348 is the FDA 510(k) clearance record for BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE, a class II device, cleared for Biolab Equipment Canada , Ltd. on under FDA product code FIP (Subsystem, Water Purification). FDA records list one 510(k) clearance for Biolab Equipment Canada , Ltd. As of , FDA records show no recalls naming K030348.

Clearance record

Decision date
Received
(260 days to decision)
Product code
FIP Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Biolab Equipment Canada , Ltd. 128 Grandview Ave., Thornhill, Ontario, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FIP

Trailing 12 months
1 clearance under product code FIP in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FIP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260