Medical Device Manufacturer · US , Baltimore , MD

Welldoc, Inc.

11 submissions · 11 cleared · Since 2010
11
Total
11
Cleared
0
Denied

Welldoc, Inc. — FDA 510(k) Submissions

Welldoc, Inc. has submitted 11 FDA 510(k) premarket notifications since 2010, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Accessories, Pump, Infusion, Calculator, Drug Dose, Continuous Glucose Monitor Informed Insulin Dose Calculator . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
BlueStar CGM insulin dose calculator
K222888 · QRX Continuous Glucose... · Chemistry
Aug 2023 322d
BlueStar and BlueStar Rx
K230813 · NDC Calculator, Drug Dose · Chemistry
Jul 2023 126d
BlueStar Rx
K203434 · NDC Calculator, Drug Dose · Chemistry
Sep 2021 289d
BlueStar Rx
K193654 · MRZ Accessories, Pump, Infusion · Chemistry
Apr 2020 99d
WellDoc BlueStar
K190013 · MRZ Accessories, Pump, Infusion · General Hospital
Nov 2019 305d
WellDoc BlueStar, WellDoc BlueStar Rx
K162532 · MRZ Accessories, Pump, Infusion · General Hospital
Jan 2017 125d
WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
K162225 · MRZ Accessories, Pump, Infusion · General Hospital
Nov 2016 106d
WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
K141273 · MRZ Accessories, Pump, Infusion · General Hospital
Jul 2014 53d
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
K120314 · MRZ Accessories, Pump, Infusion · General Hospital
Feb 2012 23d
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
K112370 · MRZ Accessories, Pump, Infusion · General Hospital
Oct 2011 58d
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
K100066 · MRZ Accessories, Pump, Infusion · General Hospital
Jul 2010 185d
Filters