510(k) Report

FDA applicant

Lumitex, Inc.

Strongsville, OH3 decisions1991–20121 recall

FDA records 3 decisions for Lumitex, Inc. (Strongsville, OH) from 1991 to 2012: 3 510(k) clearances. Most are in product codes LBI (Unit, Neonatal Phototherapy) and HJN (Transilluminator, Battery-Powered). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Lumitex, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lumitex, 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?

  • LBIUnit, Neonatal Phototherapy2decisions
  • HJNTransilluminator, Battery-Powered1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K053568Bilisoft Phototherapy SystemLumitex, Inc. · 20062cite it

What has FDA decided for it lately?

  • K120820Giraffe Blue Spot PT LiteLumitex, Inc. · 20121 recall
  • K053568Bilisoft Phototherapy SystemLumitex, Inc. · 2006
  • K912747Lulmitex Neonatal TransilluminatorLumitex, Inc. · 1991

All 3 as Lumitex, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K120820Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533…Dec 11, 2019Class II