510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222888Substantially Equivalent

BlueStar CGM insulin dose calculator

Welldoc, Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222888 is the FDA 510(k) clearance record for BlueStar CGM insulin dose calculator, a class II device, cleared for Welldoc, Inc. on under FDA product code QRX (Continuous Glucose Monitor Informed Insulin Dose Calculator). FDA's definition for product code QRX reads: "A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information". FDA records list 11 510(k) clearances for Welldoc, Inc., from to . As of , FDA records show no recalls naming K222888.

Clearance record

Decision date
Received
(322 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
Welldoc, Inc. 10221 Wincopin Cir., Suite 150, Columbia MD
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