510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191370Substantially Equivalent

DreaMed Advisor Pro

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

K191370 is the FDA 510(k) clearance record for DreaMed Advisor Pro, a class II device, cleared for DreaMed Diabetes, Ltd. on under FDA product code QCC (Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals). FDA's definition for product code QCC reads: "An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data...". FDA records list 5 510(k) clearances for DreaMed Diabetes, Ltd., from to . As of , FDA records show no recalls naming K191370.

Clearance record

Decision date
Received
(57 days to decision)
Product code
QCC Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Regulation
21 CFR 862.1358
Device class
Class II
Review panel
Clinical Chemistry
Applicant
DreaMed Diabetes, Ltd. 5 Mota Gur St., Petah Tikva, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QCC

Trailing 12 months

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

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