510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K260062Substantially Equivalent

MODI System

DreaMed Diabetes, Ltd., Petah Tikva, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(243 days to decision)
Product code
QRX Continuous Glucose Monitor Informed Insulin Dose Calculator
Regulation
21 CFR 862.1358
Device class
Class II
Review panel
Clinical Chemistry
Applicant
DreaMed Diabetes, Ltd. 14 Kaplan St., Petah Tikva, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QRX

Trailing 12 months
2 clearances under product code QRX 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 QRX, 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 20261
October 20260