# Hoffman Laboratories, LLC

- Location (FDA's records): Chatsworth, CA
- FDA decisions: 2 (2005–2006): 2 510(k) clearances
- Product codes: BZD (2)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sensor Medics Corp.: 1 (https://510kreport.com/company/sensor-medics)
- Resmed, Ltd.: 1 (https://510kreport.com/company/resmed)
- Fisher & Paykel Electronics, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-electronics)
- Lifesleep Systems, Inc.: 1 (https://510kreport.com/company/lifesleep-systems)

## Firms that cite its devices most
- Aeiomed, Inc.: 1 (https://510kreport.com/company/aeiomed)
- Deshum Medical: 1 (https://510kreport.com/company/deshum-medical)
- Viasys Sleep Systems, LLC: 1 (https://510kreport.com/company/viasys-sleep-systems)

## Its most-cited devices
- K052597: Breathex Omega Cpap Device, Model 322 (2005), cited by 3

## Recent decisions
- K061099: Breathx Nasal Pillow and Mask System, Model 011-0003 (Aug 11, 2006)
- K052597: Breathex Omega Cpap Device, Model 322 (Dec 16, 2005)

Source page: https://510kreport.com/company/hoffman-laboratories