Monarch Medical Technologies: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Monarch Medical Technologies” (first 2014, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 236 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 247 |
| 2015 | 1 | 199 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 236 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Monarch Medical Technologies took a median 236 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NDC | Calculator, Drug Dose | 3 | 3 |
Review panels
Most recent Monarch Medical Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241088 | EndoTool IV (3.1) | NDC | 2024-12-11 | 236 |
| K142918 | EndoTool SubQ | NDC | 2015-04-24 | 199 |
| K132547 | ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) | NDC | 2014-04-17 | 247 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-10-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Monarch Medical Technologies, LLC (3 510(k)s)
- Monarch Labs, LLC (2 510(k)s)
- Monarch Products, Inc. (2 510(k)s)
- The Monarch Company (1 510(k)s)
- Monarch Bioimplants GmbH (1 510(k)s)
- Monarch Medical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Monarch Medical Technologies?
FDA lists 3 510(k) clearances under the applicant name “Monarch Medical Technologies” (first 2014, latest 2024), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Monarch Medical Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Monarch Medical Technologies is 236 days.
Which FDA product codes appear under Monarch Medical Technologies?
The most frequent FDA product codes under this applicant name are NDC (Calculator, Drug Dose, 3).
Next steps
- See all 3 Monarch Medical Technologies clearances with predicates and recalls
- Run predicate analysis for product code NDC, Monarch Medical Technologies's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.