510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894106Substantially Equivalent

Drake Willock Reverse Osmosis Water Treatment Syst

Cd Medical, Inc., Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894106 is the FDA 510(k) clearance record for DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST, a class II device, cleared for Cd Medical, Inc. on under FDA product code FIP (Subsystem, Water Purification). FDA records list 11 510(k) clearances for Cd Medical, Inc., from to . As of , FDA records show no recalls naming K894106.

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
Cd Medical, Inc. 14620 NW 60th Ave., Miami Lakes FL
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