510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220494Substantially Equivalent

BreathID Hp Lab System, BreathID Smart System

Meridian Bioscience Israel Ltd., Modiin, IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220494 is the FDA 510(k) clearance record for BreathID Hp Lab System, BreathID Smart System, a class I device, cleared for Meridian Bioscience Israel , Ltd. on under FDA product code MSQ (Test, Urea (Breath Or Blood)). FDA records list 8 510(k) clearances for Meridian Bioscience Israel , Ltd., from to . As of , FDA records show no recalls naming K220494.

Clearance record

Decision date
Received
(121 days to decision)
Product code
MSQ Test, Urea (Breath Or Blood)
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Meridian Bioscience Israel , Ltd. 4 Ha'Maayan St., Modiin, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSQ

Trailing 12 months

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

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