# Epimed International, Inc.

- Location (FDA's records): Johnstown, NY
- FDA decisions: 16 (1998–2024): 16 510(k) clearances
- Names in FDA's records: Epimed International, Inc. (14); Epimed International (2)
- Product codes: BSP (6), BSO (4), GXI (2), FPA (1), CAZ (1), MIA (1), GXD (1)
- Predicates its devices cite: 19 (6 its own); citations of its devices by later devices: 16 (6 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pajunk GmbH: 3 (https://510kreport.com/company/pajunk)
- Custom Medical Concepts, Inc.: 2 (https://510kreport.com/company/custom-medical-concepts)
- Radionics, Inc.: 1 (https://510kreport.com/company/radionics)
- Medic Evaluation Devices & Instruments Corp.: 1 (https://510kreport.com/company/medic-evaluation-devices-instruments)
- Summit Medical Products, Inc.: 1 (https://510kreport.com/company/summit-medical-products)
- Arrow International, Inc.: 1 (https://510kreport.com/company/arrow-international)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Manan Medical Products, Inc.: 1 (https://510kreport.com/company/manan-medical-products)

## Firms that cite its devices most
- American Medical Technologies, Inc.: 2 (https://510kreport.com/company/american-medical-technologies)
- Innospine, Inc.: 2 (https://510kreport.com/company/innospine)
- I-Flow Corp.: 1 (https://510kreport.com/company/i-flow)
- Unisis Corp.: 1 (https://510kreport.com/company/unisis)
- Mps Acacia: 1 (https://510kreport.com/company/mps-acacia)
- Laurimed, LLC: 1 (https://510kreport.com/company/laurimed)
- Diros Technology, Inc.: 1 (https://510kreport.com/company/diros-technology)
- Micor, Inc.: 1 (https://510kreport.com/company/micor)

## Its most-cited devices
- K981329: Feth-R-Kath (1998), cited by 4
- K041843: Pencil Point Needle (2004), cited by 3
- K023140: Versa-Kath Epidural Catheter, Model 156-2124 (2003), cited by 2
- K030562: Tuohy Epidural Needle (2003), cited by 2
- K022029: Quincke Spinal Needle (2002), cited by 2
- K041021: RF Introduction Cannula (2004), cited by 1

## Recent decisions
- K232632: Racz Neurostat RF Generator (May 24, 2024)
- K200624: Percutaneous Introducer (Apr 27, 2020)
- K190256: Rulo Radiofrequency Lesion Probe (Mar 8, 2019)
- K133316: Spirol  Block (19 GA. Open End Models), (20 GA. Open End Models), (19 GA. Closed End Models), (20 GA. Closed End Models) (May 28, 2014)
- K072005: RK Epidural Needle (Feb 7, 2008)
- K053318: RX Epidural Needle (Feb 17, 2006)
- K051171: Stingray Epidural Catheter Connector (Aug 26, 2005)
- K051860: Flexible Introducer Cannula, Model 135-1837 (Aug 22, 2005)

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