Monarch Medical Technologies
Charlotte, NC, US
Monarch Medical Technologies appears in FDA device records in Charlotte, NC. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Monarch Medical Technologies between 2014 and 2024. The busiest year on record is 2020, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241088 | EndoTool IV (3.1) | NDC | Substantially Equivalent | |
| K211160 | EndoTool SubQ 2.1 | NDC | Substantially Equivalent | |
| K201619 | EndoTool IV System | NDC | Substantially Equivalent | |
| K200443 | EndoTool IV 1.10 | NDC | Substantially Equivalent | |
| K142918 | EndoTool SubQ | NDC | Substantially Equivalent | |
| K132547 | ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) | NDC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009864844 | 3009864844 | Monarch Medical Technologies | 112 S. Tryon Street, Charlotte, NC 28284 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0354-2020 | EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) | Product was distributed prior to approval or clearance from FDA. | Class II | Terminated | |
| Z-1786-2019 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain