510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103115Substantially Equivalent

Prodigy Diabetes Management Software

Prodigy Diabetes Care, LLC, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103115 is the FDA 510(k) clearance record for PRODIGY DIABETES MANAGEMENT SOFTWARE, a class II device, cleared for Prodigy Diabetes Care, LLC on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list 3 510(k) clearances for Prodigy Diabetes Care, LLC, from to . As of , FDA records show no recalls naming K103115.

Clearance record

Decision date
Received
(356 days to decision)
Product code
NBW System, Test, Blood Glucose, Over The Counter
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Prodigy Diabetes Care, LLC 1468 Harwell Ave., Crofton MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBW

Trailing 12 months
2 clearances under product code NBW in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260