510(k) Report

FDA applicant

Spectrawave, Inc.

Bedford, MA6 decisions2023–20250 recalls

FDA records 6 decisions for Spectrawave, Inc. (Bedford, MA) from 2023 to 2025: 6 510(k) clearances. Most are in product codes NQQ (System, Imaging, Optical Coherence Tomography…) and QHA (X-Ray Angiographic Imaging Based Coronary…). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Spectrawave, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2023: 22025: 4
2023high 4 (2025) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Spectrawave, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spectrawave, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NQQSystem, Imaging, Optical Coherence Tomography (Oct)5decisions
  • QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 146 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 4 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K221257SpectraWAVE Imaging SystemSpectrawave, Inc. · 20233cite it
  • K230691HyperVue™ Imaging SystemSpectrawave, Inc. · 20231cites it

What has FDA decided for it lately?

  • K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc. · 2025
  • K251355X1-FFRSpectrawave, Inc. · 2025
  • K251198HyperVue™ SoftwareSpectrawave, Inc. · 2025
  • K243016Starlight Imaging CatheterSpectrawave, Inc. · 2025
  • K230691HyperVue™ Imaging SystemSpectrawave, Inc. · 2023
  • K221257SpectraWAVE Imaging SystemSpectrawave, Inc. · 2023

All 6 as Spectrawave, Inc. →