510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K052804Substantially Equivalent

Breathkey Model G10/breathkey Model G30x

Omega Point Systems, LLC, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052804 is the FDA 510(k) clearance record for BREATHKEY MODEL G10/BREATHKEY MODEL G30X, a class I device, cleared for Omega Point Systems, LLC on under FDA product code DJZ (Devices, Breath Trapping, Alcohol). FDA records list one 510(k) clearance for Omega Point Systems, LLC. As of , FDA records show no recalls naming K052804.

Clearance record

Decision date
Received
(66 days to decision)
Product code
DJZ Devices, Breath Trapping, Alcohol
Regulation
21 CFR 862.3050
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Omega Point Systems, LLC 310 Ter. Ave., Cincinnati OH
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DJZ

Trailing 12 months

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

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