Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spectrawave, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
170 daysmedian FDA review time
302 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253101 | HyperVue™ Imaging System - Integrated | Spectrawave, Inc. | 2025-12-15 | 82 | 0 |
| K251355 | X1-FFR | Spectrawave, Inc. | 2025-10-17 | 170 | 0 |
| K251198 | HyperVue™ Software | Spectrawave, Inc. | 2025-07-16 | 90 | 0 |
| K243016 | Starlight Imaging Catheter | Spectrawave, Inc. | 2025-03-20 | 174 | 0 |
| K230691 | HyperVue™ Imaging System | Spectrawave, Inc. | 2023-06-07 | 86 | 0 |
| K221257 | SpectraWAVE Imaging System | Spectrawave, Inc. | 2023-02-28 | 302 | 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