# Health Line International Corporation

- Location (FDA's records): Salt Lake City, UT
- FDA decisions: 12 (2006–2026): 12 510(k) clearances
- Product codes: FOZ (3), LJS (2), FPA (2), DQY (1), MSD (1), MPB (1), NIE (1), DYB (1)
- 510(k) review time since 2016: median 85 days, against 140 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 19 (4 its own); citations of its devices by later devices: 9 (4 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
- Medcomp: 3 (https://510kreport.com/company/medcomp)
- Rita Medical Systems: 2 (https://510kreport.com/company/rita-medical-systems)
- Arrow Intl., Inc.: 1 (https://510kreport.com/company/arrow-intl)
- Pfm Medical, Inc.: 1 (https://510kreport.com/company/pfm-medical)
- Medcomp ( Medical Components): 1 (https://510kreport.com/company/medcomp-medical-components)
- Medical Components, Inc.: 1 (https://510kreport.com/company/medical-components)
- Quest Medical, Inc.: 1 (https://510kreport.com/company/quest-medical)
- Covidien: 1 (https://510kreport.com/company/covidien)

## Firms that cite its devices most
- Health Line International Corporation (Hlic): 1 (https://510kreport.com/company/health-line-international-hlic)
- Zyno Medical, LLC: 1 (https://510kreport.com/company/zyno-medical)
- Semprus Biosciences: 1 (https://510kreport.com/company/semprus-biosciences)
- Haolang Medical USA Corporation: 1 (https://510kreport.com/company/haolang-medical-usa)
- Centurion Medical Products Corporation: 1 (https://510kreport.com/company/centurion-medical-products)

## Its most-cited devices
- K101329: Synergy CT Picc (2010), cited by 4
- K160448: Artline (2016), cited by 1
- K130851: Cascade Hemodialysis/Apheresis Catheter (2014), cited by 1
- K130034: Uni-Picc (2013), cited by 1
- K060352: Health Line International Corporations,S IV Administrative Sets (2006), cited by 1
- K140270: Nexus Midline CT Catheter (2014), cited by 1

## Recent decisions
- K261950: Health Line Tearaway Introducer (Jun 22, 2026)
- K222170: Power Acute Triple Lumen Hemodialysis Catheter (Jan 13, 2023)
- K200426: Acute Dual Lumen Hemodialysis Catheter (Dec 24, 2020)
- K200263: Health Line CT Midline Catheter (Mar 12, 2020)
- K192533: Health Line CT CVC (Dec 10, 2019)
- K160448: Artline (Jul 12, 2016)
- K140270: Nexus Midline CT Catheter (Aug 20, 2014)
- K130851: Cascade Hemodialysis/Apheresis Catheter (Jan 9, 2014)

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