Who else makes this device?

Name: EndoTool SubQ
Brand: EndoTool SubQ

Anesthesiology › DiagnosticCalculator, Drug Dose

EndoTool SubQ

EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient’s next dose of insulin to be administered subcutaneously…

Registry build 21.09.26

EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient’s next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with hyperglycemia including adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) and when indicated a carbohydrate dose based on the prescribing healthcare Provider’s nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.

2manufacturers in China registered for this device type

1catalogue number

6510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NDC
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44

Record

Regulatory record for EndoTool SubQ
Listed by	Monarch Medical Technologies, United States
FDA product code	NDC
Device type	Calculator, Drug Dose
Device class	Class 2
Regulation	21 CFR 868.1890
Establishment	Complaint-file establishment, Manufacturer
510(k)	K211160
Record published	2023-08-23
Record revised	2024-05-01 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for EndoTool SubQ
Catalogue number	Size	Status
SubQ 2.0		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Welldoc	Welldoc	16
Insulia	Voluntis	6
Healthfirst Cares Rx	Welldoc	6
Bluestar	Welldoc	6
Healthfirst Cares	Welldoc	5
Conifer Connect Diabetes	Welldoc	5
Welldoc Rx	Welldoc	5
LivingConnected Diabetes Rx	Welldoc	5
Bluestar Rx	Welldoc	5
Conifer Connect Diabetes Rx	Welldoc	5
inpen™	Medtronic Minimed	5
TempoSmart	Welldoc	4

Showing 12 of 36. All products under Calculator, Drug Dose

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K241088	2024-12-11
K211160	2021-10-28
K201619	2020-08-07
K200443	2020-03-17
K142918	2015-04-24
K132547	2014-04-17

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2019-10-01	Class II	Software change control	Product was distributed prior to approval or clearance from FDA.	6 units	2026-02-10
2019-05-03	Class II	Software change control	Insulin dosing calculations were erroneously high.	83 downloads

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.