510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K944037Substantially Equivalent

Diacide Hd Disinfecting Solution

Gulfstream Medical, Winthrop MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944037 is the FDA 510(k) clearance record for DIACIDE HD DISINFECTING SOLUTION, a class I device, cleared for Gulfstream Medical on under FDA product code LRJ (Disinfectant, Medical Devices). FDA records list 2 510(k) clearances for Gulfstream Medical, from to . As of , FDA records show no recalls naming K944037.

Clearance record

Decision date
Received
(216 days to decision)
Product code
LRJ Disinfectant, Medical Devices
Regulation
21 CFR 880.6890
Device class
Class I
Review panel
General Hospital
Applicant
Gulfstream Medical 550 Pleasant St., Winthrop MA
510(k) summary
Statement
Third party review
No

Clearances, product code LRJ

Trailing 12 months

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

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