Spectrawave, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Spectrawave, Inc.” (first 2023, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 130 days. Since 2017 the median was 130 days, against 118 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 |
|---|---|---|
| 2023 | 2 | 194 |
| 2024 | 0 | — |
| 2025 | 4 | 130 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spectrawave, Inc. took a median 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 5 | 5 |
| QHA | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | 1 | 1 |
Review panels
Most recent Spectrawave, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253101 | HyperVue Imaging System - Integrated | NQQ | 2025-12-15 | 82 |
| K251355 | X1-FFR | QHA | 2025-10-17 | 170 |
| K251198 | HyperVue Software | NQQ | 2025-07-16 | 90 |
| K243016 | Starlight Imaging Catheter | NQQ | 2025-03-20 | 174 |
| K230691 | HyperVue Imaging System | NQQ | 2023-06-07 | 86 |
| K221257 | SpectraWAVE Imaging System | NQQ | 2023-02-28 | 302 |
Recalls
openFDA lists no recalls under a recalling firm named Spectrawave, 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.
Device clinical trials
An industry sponsor named Spectrawave, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05241665: First in Human Study (Completed, started 2022-07-28)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spectrawave, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Spectrawave, Inc.” (first 2023, latest 2025), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spectrawave, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spectrawave, Inc. is 130 days. Since 2017: 130 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spectrawave, Inc.?
The most frequent FDA product codes under this applicant name are NQQ (System, Imaging, Optical Coherence Tomography (Oct), 5); QHA (X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device, 1).
Next steps
- See all 6 Spectrawave, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NQQ, Spectrawave, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.