Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Recensmedical, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
592 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253114 | TargetCool™ (RM-DT02W) | Recensmedical, Inc. | 2025-10-16 | 22 | 0 |
| K253348 | TargetCool-e | Recensmedical, Inc. | 2025-10-15 | 15 | 0 |
| DEN230011 | OcuCool | Recensmedical, Inc. | 2024-09-30 | 592 | 0 |
| K230599 | TargetCool™ | Recensmedical, Inc. | 2023-06-22 | 111 | 0 |
| K221234 | TargetCool | Recensmedical, Inc. | 2022-07-22 | 84 | 0 |
| K220674 | TargetCool | Recensmedical, Inc. | 2022-03-31 | 23 | 0 |
| K203481 | CryoVIVE | Recensmedical, Inc. | 2021-05-13 | 167 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda