510(k) Report

FDA applicant

Spectranetrics

Colorado Springs, CO1 decision2015–20150 recalls

FDA records 1 decision for Spectranetrics (Colorado Springs, CO) in 2015: 1 510(k) clearance. All are in product code PNO (Catheter, Percutaneous, Cutting/Scoring). Its devices cite 2 predicates, 0 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Spectranetrics by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • PNOCatheter, Percutaneous, Cutting/Scoring1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics · 20153cite it

What has FDA decided for it lately?

  • K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics · 2015

The one decision as Spectranetrics →