# Oconnell Regulatory Consultants, Inc.

- Location (FDA's records): Stoneham, MA
- FDA decisions: 1 (2025–2025): 1 510(k) clearance
- Product codes: CBK (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (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
- Breas Medical AB: 1 (https://510kreport.com/company/breas-medical)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)

## Recent decisions
- K232365: Vivo 45 LS (Dec 19, 2025)

Source page: https://510kreport.com/company/oconnell-regulatory-consultants