Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Perspectum, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
279 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | 2026-03-09 | 159 | 0 |
| K241925 | VitruvianScan (v1.0) | Perspectum, Ltd. | 2024-10-02 | 93 | 0 |
| K212565 | CoverScan v1 | Perspectum, Ltd. | 2022-05-19 | 279 | 0 |
| K203280 | Hepatica v1 (Hepatica v1.0.0) | Perspectum, Ltd. | 2021-01-12 | 67 | 0 |
| K202170 | LiverMultiScan | Perspectum, Ltd. | 2020-10-02 | 60 | 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