Data / Medical devices / United States / Monarch Medical Technologies
Monarch Medical Technologies: FDA-registered device maker in Charlotte, NC, United States, 4 510(k) clearances
Monarch Medical Technologies is registered with the FDA (registration 3009864844) in Charlotte, NC, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated December 11, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009864844
- Address
- 112 S. Tryon Street Suite 800, Charlotte, NC, United States, 28284
- Owner or operator
- Glooko, Inc (10038854)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 25, 2025
- Registered through
- 2026
- Brand names listed
- EndoTool IV 1.10, EndoTool IV 3.1, EndoTool IV System, EndoTool SubQ 2.1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Drug Dose | NDC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 11, 2024 | K241088 | EndoTool IV (3.1) | NDC | Substantially Equivalent | Monarch Medical Technologies | accessdata.fda.gov |
| October 28, 2021 | K211160 | EndoTool SubQ 2.1 | NDC | Substantially Equivalent | Monarch Medical Technologies, LLC | accessdata.fda.gov |
| August 7, 2020 | K201619 | EndoTool IV System | NDC | Substantially Equivalent | Monarch Medical Technologies, LLC | accessdata.fda.gov |
| March 17, 2020 | K200443 | EndoTool IV 1.10 | NDC | Substantially Equivalent | Monarch Medical Technologies, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 1, 2019 | 83926 | Class II | Terminated | EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) | Product was distributed prior to approval or clearance from FDA. | accessdata.fda.gov |
| May 3, 2019 | 82828 | Class II | Ongoing | Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10. | Insulin dosing calculations were erroneously high. | accessdata.fda.gov |
Compare with other makers
Updated December 11, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.