510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100066Substantially Equivalent

Diabetesmanager System, Diabetesmanager-Rx System Model Version 1.1

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

K100066 is the FDA 510(k) clearance record for DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1, a class II device, cleared for Welldoc, Inc. on under FDA product code MRZ (Accessories, Pump, Infusion). FDA records list 11 510(k) clearances for Welldoc, Inc., from to . As of , FDA records show no recalls naming K100066.

Clearance record

Decision date
Received
(185 days to decision)
Product code
MRZ Accessories, Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Welldoc, Inc. 1501 Saint Paul St., Baltimore MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRZ

Trailing 12 months

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

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