Recensmedical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Recensmedical, Inc.” (first 2021, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 54 days. Since 2017 the median was 54 days, against 88 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2021 | 1 | 167 |
| 2022 | 2 | 54 |
| 2023 | 1 | 111 |
| 2024 | 0 | — |
| 2025 | 2 | 18 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Recensmedical, Inc. took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 6 | 6 |
| QZQ | 1 | 0 |
Review panels
Most recent Recensmedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253114 | TargetCool (RM-DT02W) | GEH | 2025-10-16 | 22 |
| K253348 | TargetCool-e | GEH | 2025-10-15 | 15 |
| K230599 | TargetCool | GEH | 2023-06-22 | 111 |
| K221234 | TargetCool | GEH | 2022-07-22 | 84 |
| K220674 | TargetCool | GEH | 2022-03-31 | 23 |
| K203481 | CryoVIVE | GEH | 2021-05-13 | 167 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230011 | De Novo | 2024-09-30 |
Recalls
openFDA lists no recalls under a recalling firm named Recensmedical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Recensmedical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Recensmedical, Inc.” (first 2021, latest 2025), plus 1 De Novo decision, across 2 product codes 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 Recensmedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Recensmedical, Inc. is 54 days. Since 2017: 54 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Recensmedical, Inc.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 6); QZQ (device, 1).
Next steps
- See all 6 Recensmedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, Recensmedical, 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 (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.