# International Regulatory Consultants

- Location (FDA's records): Gaithersburg, MD
- FDA decisions: 5 (1994–1998): 5 510(k) clearances
- Product codes: FMF (1), FAD (1), FMI (1), LMD (1), FLL (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 10 (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
- Algotec Systems, Ltd.: 1 (https://510kreport.com/company/algotec-systems)

## Firms that cite its devices most
- Coloplast Corp.: 3 (https://510kreport.com/company/coloplast)
- Eastman Kodak Company: 1 (https://510kreport.com/company/eastman-kodak)
- Intuitive Imaging Informatics, LLC: 1 (https://510kreport.com/company/intuitive-imaging-informatics)
- Porges Corp.: 1 (https://510kreport.com/company/porges)
- Mitra Imaging, Inc.: 1 (https://510kreport.com/company/mitra-imaging)
- Spintech, Inc.: 1 (https://510kreport.com/company/spintech)
- Intracom Corp.: 1 (https://510kreport.com/company/intracom)
- Philips Medical Systems (Cleveland), Inc.: 1 (https://510kreport.com/company/philips-medical-systems-cleveland)

## Its most-cited devices
- K971347: Medisurf (1997), cited by 5
- K981591: Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent (1998), cited by 4
- K962614: Shifa Sterile Disposable Syringes (1996), cited by 1

## Recent decisions
- K981591: Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent (Oct 9, 1998)
- K971347: Medisurf (Jul 3, 1997)
- K962614: Shifa Sterile Disposable Syringes (Sep 6, 1996)
- K950012: Dispomedic Disposable Syringes and Needles (Aug 18, 1995)
- K935280: Memotherm 10 Baby Thermometer (Oct 19, 1994)

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