Mercator Medsystems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mercator Medsystems, Inc.” (first 2006, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 48 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 110 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 178 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mercator Medsystems, Inc. took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | 4 | 4 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
Review panels
Most recent Mercator Medsystems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210339 | Bullfrog Micro-Infusion Device | KRA | 2021-08-02 | 178 |
| K161402 | Bullfrog Micro-Infusion Device | KRA | 2016-08-18 | 90 |
| K153501 | Bullfrog Micro-Infusion Device | KRA | 2016-04-15 | 130 |
| K131401 | BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER | EOQ | 2013-07-02 | 48 |
| K062752 | MERCATOR MICROSYRINGE II INFUSION CATHETER | KRA | 2006-12-07 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Mercator Medsystems, Inc..
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.
Device clinical trials
An industry sponsor named Mercator Medsystems, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02469532: DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes (Completed, started 2015-05)
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.
- Mercator Medical (Thailand), Ltd. (7 510(k)s)
- Mercator Healthcare , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mercator Medsystems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Mercator Medsystems, Inc.” (first 2006, latest 2021), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mercator Medsystems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mercator Medsystems, Inc. is 90 days.
Which FDA product codes appear under Mercator Medsystems, Inc.?
The most frequent FDA product codes under this applicant name are KRA (Catheter, Continuous Flush, 4); EOQ (Bronchoscope (Flexible Or Rigid), 1).
Next steps
- See all 5 Mercator Medsystems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KRA, Mercator Medsystems, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.