Revmedx, Inc.: FDA clearances and approvals
Revmedx, Inc. has 6 FDA 510(k) clearances (first 2015, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 98 days. Since 2017 its median was 109 days, against 109 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Revmedx, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 84 |
| 2016 | 1 | 107 |
| 2017 | 1 | 88 |
| 2018 | 1 | 130 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 175 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 44 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Revmedx, Inc.'s cleared 510(k)s took a median 109 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PGZ | Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use | 7 | 6 |
Review panels
Most recent Revmedx, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253290 | XSTAT P15 | PGZ | 2025-11-12 | 44 |
| K210676 | XSTAT 30 Pouch | PGZ | 2021-08-27 | 175 |
| K180051 | XSTAT 30, 1-Pack | PGZ | 2018-05-18 | 130 |
| K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | PGZ | 2017-05-01 | 88 |
| K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack | PGZ | 2016-07-28 | 107 |
| K152624 | XSTAT 30, 3-PACK, XSTAT 30, 1-PACK | PGZ | 2015-12-07 | 84 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130016 | De Novo | Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use | 2014-04-03 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-08-12.
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.
Frequently asked questions
How many FDA 510(k) clearances does Revmedx, Inc. have?
Revmedx, Inc. has 6 FDA 510(k) clearances (first 2015, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Revmedx, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Revmedx, Inc.'s cleared 510(k)s is 98 days. Since 2017: 109 days, versus 109 days for all cleared 510(k)s in the same product codes.
What devices does Revmedx, Inc. make?
Its most frequent FDA product codes are PGZ (Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use, 7).
Has Revmedx, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Revmedx, Inc; the most recent began 2015-08-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Revmedx, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PGZ, Revmedx, 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.