Moerae Matrix, Inc.: FDA clearances and approvals
Moerae Matrix, Inc. has 1 FDA 510(k) clearance (first 2014, latest 2014), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 270 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 270 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GBX | Catheter, Irrigation | 1 | 1 |
| PDW | Internal Tissue Marker | 1 | 0 |
Review panels
Most recent Moerae Matrix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131659 | MOERAE VEIN PREPARATION KIT | GBX | 2014-03-03 | 270 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130004 | De Novo | Internal Tissue Marker | 2014-12-18 |
Recalls
openFDA lists no recalls under a recalling firm named Moerae Matrix, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Moerae Matrix, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Moerae Matrix, Inc. have?
Moerae Matrix, Inc. has 1 FDA 510(k) clearance (first 2014, latest 2014), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Moerae Matrix, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Moerae Matrix, Inc.'s cleared 510(k)s is 270 days.
What devices does Moerae Matrix, Inc. make?
Its most frequent FDA product codes are GBX (Catheter, Irrigation, 1); PDW (Internal Tissue Marker, 1).
Has Moerae Matrix, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Moerae Matrix, Inc. Related entities may recall under other names.
Next steps
- See all 1 Moerae Matrix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GBX, Moerae Matrix, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.