510(k) Report

FDA applicant

Illuminoss Medical, Inc.

East Providence, RI6 decisions2018–20240 recalls

FDA records 6 decisions for Illuminoss Medical, Inc. (East Providence, RI) from 2018 to 2024: 6 510(k) clearances. All are in product code QAD (Rod, Fixation, Intramedullary And Accessories…). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 30 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 3 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2024

2018: 22020: 32024: 1
2018high 3 (2020) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Illuminoss Medical, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Illuminoss Medical, Inc.’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?

  • QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated6decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 30 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 3 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.

  • K181228IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. · 20181cites it
  • K202887IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. · 20201cites it
  • K201961IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. · 20201cites it

What has FDA decided for it lately?

  • K233436IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. · 2024
  • K202887IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. · 2020
  • K201961IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. · 2020
  • K200295IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. · 2020
  • K183145IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. · 2018
  • K181228IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. · 2018

All 6 as Illuminoss Medical, Inc. →