General Hospital · 510(k) · 2019
WellDoc BlueStar
WellDoc, Inc.. Cleared by FDA on 4 November 2019 under submission K190013, product code MRZ (accessories, pump, infusion). What FDA's record says, in FDA's words.
Device record · K190013
- Device. WellDoc BlueStarDEVICE
- Company. WellDoc, Inc.COMPANY
- Decision. 4 November 2019, 510(k), substantially equivalent (traditional review); received 3 January 2019DECISION
- Panel. General HospitalPANEL
- Product code. MRZ, Accessories, Pump, InfusionCODE
- Regulation. 21 CFR 880.5725, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The WellDoc BlueStar System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The BlueStar System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 543 reports filed against devices carrying product code MRZ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
15 September 2026 · Other · Set Sapphire DC Y-Site · report MW6002329
Around 1530, patient reports blood glucose (BG) dropped into the 50s again and did not improve after drinking 3 glasses of pineapple juice and eating 6 glucose gummies. Patient scheduled a teledoc appointment with MD who advised her to go to Emergency Room. Patient's glucose was in the 140s by the time she was seen at the (b)(6) Emergency Room. Patient reports that no interventions were performed for BG, but patient was told she has a UTI and prescribed antibiotics. RN advised that patient […]
9 September 2026 · Malfunction · SapphireConnect Single Unit · Eitan Medical Ltd. · report 3010293992-2026-00077
This complaint was reported by a customer from USA. Power supply issue.
13 August 2026 · Malfunction · Sapphire Power Supply-US · Eitan Medical Ltd. · report 3010293992-2026-00070
6 August 2026 · Injury · Cadd Solis Ambulatory Pump · InfuSystem Inc. · report MW6000654
patient reports they are having a double pump malfunction & getting downstream occlusion alert. patient reports the first pump gave alert last night (b)(6) 2026 at 8pm so a cassette change was completed but pump still alerted. patient switched to their second pump & thatpump also gave downstream occlusion alert at 4:30am today. still no resolution after completing troubleshooting: changing pumps, changing cassette, inspecting tubing for kinks, replacing batteries. RPH- REGISTERED PHARMACIST […]
6 August 2026 · Other · Cadd Solis Ambulatory Pump · InfuSystem Inc. · report MW6000507
patient reports they are having a double pump malfunction & getting downstream occlusionalert. patient reports the first pump gave alert last night (b)(6) 2026 at 8pm so a cassettechange was completed but pump still alerted. patient switched to their second pump & thatpump also gave downstream occlusion alert at 4:30am today. still no resolution aftercompleting troubleshooting: changing pumps, changing cassette, inspecting tubing forkinks, replacing batteries. RPH- REGISTERED PHARMACIST […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MRZ, in General Hospital, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.