# Profile Therapeutics Plc

- Location (FDA's records): Murrysville, PA
- FDA decisions: 3 (2004–2005): 3 510(k) clearances
- Product codes: CAF (3)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 6 (1 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
- Medic-Aid, Ltd.: 3 (https://510kreport.com/company/medic-aid)
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)
- Vortran Medical Technology 1, Inc.: 1 (https://510kreport.com/company/vortran-medical-technology-1)
- Medtronic Minimed: 1 (https://510kreport.com/company/medtronic-minimed)

## Firms that cite its devices most
- Activaero America, Inc.: 2 (https://510kreport.com/company/activaero-america)
- Respironics Respiratory Drug Delivery (Uk), Ltd.: 2 (https://510kreport.com/company/respironics-respiratory-drug-delivery-uk)
- Pari Respiratory Equipment, Inc.: 1 (https://510kreport.com/company/pari-respiratory-equipment)

## Its most-cited devices
- K042991: I-Neb Aad System (2005), cited by 2
- K052941: I-Neb Insight Aad System (2005), cited by 2
- K030747: Prodose Aad System (2004), cited by 2

## Recent decisions
- K052941: I-Neb Insight Aad System (Dec 9, 2005)
- K042991: I-Neb Aad System (Sep 23, 2005)
- K030747: Prodose Aad System (Apr 22, 2004)

Source page: https://510kreport.com/company/profile-therapeutics