# Helix Medical, Inc.

- Location (FDA's records): Santa Barbera, CA
- FDA decisions: 18 (1989–2013): 18 510(k) clearances
- Names in FDA's records: Helix Medical, Inc. (14); Helix Medical, LLC (4)
- Product codes: EWL (12), FDF (1), LRC (1), LFB (1), GBW (1), JOH (1), BYD (1)
- Predicates its devices cite: 14 (8 its own); citations of its devices by later devices: 10 (8 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Atos Medical AB: 1 (https://510kreport.com/company/atos-medical)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)
- E. Benson Hood Laboratories, Inc.: 1 (https://510kreport.com/company/e-benson-hood-laboratories)
- Silmed, Inc.: 1 (https://510kreport.com/company/silmed)
- Xomed, Inc.: 1 (https://510kreport.com/company/xomed)
- Bivona Medical Technologies: 1 (https://510kreport.com/company/bivona-medical-technologies)

## Firms that cite its devices most
- United States Endoscopy Group, Inc.: 1 (https://510kreport.com/company/united-states-endoscopy-group)
- Atos Medical AB: 1 (https://510kreport.com/company/atos-medical)

## Its most-cited devices
- K932120: Blom-Singer Indwelling Low Pressure Voice Prosthes (1994), cited by 3
- K945287: Inhealth Blom-Singer Indwelling Valved Insert Accessory Device (1994), cited by 1
- K991587: Blom-Singer Indwelling 2000 Voice Prosthesis (1999), cited by 1
- K930105: Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S. (1993), cited by 1
- K932163: Blom-Singer Voice Prosthesis Flushing Pipet (1993), cited by 1
- K023259: Inhealth Soft Sleeve Colonoscope Splint, Model CS1200 (2002), cited by 1

## Recent decisions
- K130736: Blom-Singer Adjustable BI-Fianged Fistula Prosthesis (Dec 17, 2013)
- K131745: Blom-Singer Septal Perforation Prosthesis (Sep 17, 2013)
- K093258: Blom-Singer Indwelling Tep Occluder (Mar 3, 2010)
- K082206: Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 Series (Sep 4, 2008)
- K023259: Inhealth Soft Sleeve Colonoscope Splint, Model CS1200 (Dec 26, 2002)
- K991587: Blom-Singer Indwelling 2000 Voice Prosthesis (Jun 25, 1999)
- K945287: Inhealth Blom-Singer Indwelling Valved Insert Accessory Device (Dec 9, 1994)
- K945288: Inhealth Blom-Singer Indwelling Plug Insert Accessory Device (Dec 2, 1994)

Source page: https://510kreport.com/company/helix-medical