510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042797Substantially Equivalent

Wro 300 Water Purification System for Hemodialysis

Gambro Renal Products, Lakewood CO / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042797 is the FDA 510(k) clearance record for WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS, a class II device, cleared for Gambro Renal Products on under FDA product code FIP (Subsystem, Water Purification). FDA records list 37 510(k) clearances for Gambro Renal Products, from to . As of , FDA records show no recalls naming K042797.

Clearance record

Decision date
Received
(152 days to decision)
Product code
FIP Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gambro Renal Products 10810 W Collins Ave., Lakewood CO
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