Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K944776Substantially Equivalent

Clear Blue Endoscopic Lens Fog Rduction Solution & Cleaning Kit

Blue Planet Industries, Inc., Plymouth MN / Traditional, Substantially Equivalent

K944776 is the FDA 510(k) clearance record for CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT, a class II device, cleared for Blue Planet Industries, Inc. on under FDA product code FEB (Accessories, Cleaning, For Endoscope). FDA's definition for product code FEB reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 3 510(k) clearances for Blue Planet Industries, Inc., from to . As of , FDA records show no recalls naming K944776.

Clearance record

Decision date
Received
(35 days to decision)
Product code
FEB Accessories, Cleaning, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Blue Planet Industries, Inc. 14224 43rd. Ave. N., Plymouth MN
510(k) summary
Statement
Third party review
No

Clearances, product code FEB

Trailing 12 months

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

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