510(k) Report

FDA applicant

National Biological Corp.

Twinsburg, OH28 decisions1977–20152 recalls

FDA records 28 decisions for National Biological Corp. (Twinsburg, OH) from 1977 to 2015: 28 510(k) clearances. Most are in product codes FTC (Light, Ultraviolet, Dermatological) and KGL (Cabinet, Phototherapy (Puva)). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “National Biological Corporation”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2015

2007: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2017

2008: 12017: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like National Biological Corp.’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?

  • FTCLight, Ultraviolet, Dermatological27decisions
  • KGLCabinet, Phototherapy (Puva)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 1 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.

  • K041212Houva 3 Phototherapy SystemNational Biological Corp. · 20044cite it
  • K885026Houva II UvbNational Biological Corp. · 19893cite it
  • K934808Uvisol and Uvisol IINational Biological Corp. · 19932cite it
  • K904427Panosol II Uvb-206National Biological Corp. · 19902cite it
  • K982082Handisol Wound HealingNational Biological Corp. · 19982cite it
  • K885025Houva II UvaNational Biological Corp. · 19892cite it

What has FDA decided for it lately?

  • K150912Houva-NET Control SystemNational Biological Corporation · 2015
  • K070934Panosol II Tru-Blu, Model Ubl-417National Biological Corp. · 2007
  • K041212Houva 3 Phototherapy SystemNational Biological Corp. · 20041 recall
  • K982082Handisol Wound HealingNational Biological Corp. · 1998
  • K934808Uvisol and Uvisol IINational Biological Corp. · 1993
  • K924969Phototherapy TimerNational Biological Corp. · 1993
  • K924077HandisolNational Biological Corp. · 1992
  • K904427Panosol II Uvb-206National Biological Corp. · 1990

All 27 as National Biological Corp. →The one decision as National Biological Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K872604Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a…Jan 27, 2017Class II
  • K041212HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10…Feb 19, 2008