# Lumitex, Inc.

- Location (FDA's records): Strongsville, OH
- FDA decisions: 3 (1991–2012): 3 510(k) clearances
- Product codes: LBI (2), HJN (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ohmeda Medical: 1 (https://510kreport.com/company/ohmeda-medical)

## Firms that cite its devices most
- Bionix Development Corp.: 1 (https://510kreport.com/company/bionix-development)
- Natus Medical, Inc.: 1 (https://510kreport.com/company/natus-medical)

## Its most-cited devices
- K053568: Bilisoft Phototherapy System (2006), cited by 2

## Recent decisions
- K120820: Giraffe Blue Spot PT Lite (Jun 8, 2012)
- K053568: Bilisoft Phototherapy System (Apr 17, 2006)
- K912747: Lulmitex Neonatal Transilluminator (Dec 24, 1991)

Source page: https://510kreport.com/company/lumitex