# Kapp Surgical Instrument, Inc.

- Location (FDA's records): Warrensville, OH
- FDA decisions: 9 (1984–2021): 9 510(k) clearances
- Product codes: NEU (2), HRS (2), HTN (1), KWI (1), KXE (1), DWF (1), GAD (1)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 3 (1 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
- Mri Devices Corp.: 1 (https://510kreport.com/company/mri-devices)
- Dlp, Inc.: 1 (https://510kreport.com/company/dlp)
- Med-Edge, Inc.: 1 (https://510kreport.com/company/med-edge)
- Voss Medical Products: 1 (https://510kreport.com/company/voss-medical-products)

## Firms that cite its devices most
- Pantheon Medical: 1 (https://510kreport.com/company/pantheon-medical)
- Mondeal Medical Systems GmbH: 1 (https://510kreport.com/company/mondeal-medical-systems)

## Its most-cited devices
- K050657: Mondeal Contour HO System (2005), cited by 1
- K050384: Kapp Bari-Ring, Model KS-BR-2005 (2006), cited by 1
- K050655: Mondeal Radius HO System, Model KS-MR-2005 (2005), cited by 1

## Recent decisions
- K200289: Michler-Kapp Cardiovascular Vent Catheter (Jan 28, 2021)
- K072216: Kapp Bari-Ring Endoscopic Marker, Model K-9536 (Nov 9, 2007)
- K050384: Kapp Bari-Ring, Model KS-BR-2005 (Jan 13, 2006)
- K050657: Mondeal Contour HO System (Aug 8, 2005)
- K050655: Mondeal Radius HO System, Model KS-MR-2005 (Aug 8, 2005)
- K033930: Kapp Custom Ulnar Head Wrist Implant (Jul 28, 2004)
- K030237: Kapp Custom Radial Head Elbow Implant (Aug 29, 2003)
- K844177: Cosgrove Mitral Valve Retractor (Nov 8, 1984)

Source page: https://510kreport.com/company/kapp-surgical-instrument