# Navilyst Medical, Inc.

- Location (FDA's records): Marlborough, MA
- FDA decisions: 35 (2009–2017): 35 510(k) clearances
- Product codes: LJS (16), FGE (4), LJT (4), DQO (3), FOZ (2), DRE (2), DXT (1), MSD (1), FMF (1), DTL (1)
- 510(k) review time since 2016: median 63 days, against 101 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 80 (45 its own); citations of its devices by later devices: 55 (45 its own)
- Recalls linked to its devices: 97 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 17 (https://510kreport.com/company/boston-scientific)
- C.R. Bard, Inc.: 4 (https://510kreport.com/company/cr-bard)
- Catheter Innovations, Inc.: 3 (https://510kreport.com/company/catheter-innovations)
- Pfm Medical, Inc.: 3 (https://510kreport.com/company/pfm-medical)
- North American Instrument Corp.: 2 (https://510kreport.com/company/north-american-instrument)
- AngioDynamics, Inc.: 2 (https://510kreport.com/company/angiodynamics)
- Scimed Life Systems, Inc.: 1 (https://510kreport.com/company/scimed-life-systems)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)

## Firms that cite its devices most
- Access Vascular, Inc.: 2 (https://510kreport.com/company/access-vascular)
- Instylla, Inc.: 1 (https://510kreport.com/company/instylla)
- L&Z Us, Inc.: 1 (https://510kreport.com/company/l-z-us)
- AngioDynamics, Inc.: 1 (https://510kreport.com/company/angiodynamics)
- Summit Access, LLC: 1 (https://510kreport.com/company/summit-access)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Spectrum Vascular: 1 (https://510kreport.com/company/spectrum-vascular)

## Its most-cited devices
- K121089: Nmi Picc Iii (2012), cited by 6
- K093366: Nmi Picc II (2009), cited by 5
- K091261: Nmi Picc (2009), cited by 5
- K111906: Xcela Hybrid Picc with Pasv Valve Technology (2011), cited by 4
- K101326: NMI IC (2010), cited by 3
- K140266: Nmi Picc IV (2014), cited by 3

## Recent decisions
- K163452: PICC Maximal Barrier Nursing Kit (Feb 3, 2017)
- K161866: BioFlo Midline Catheter (Sep 8, 2016)
- K151239: Nmi Dual Port II (Jun 6, 2016)
- K153228: NMI Port, NMI Port II (Dec 4, 2015)
- K152069: Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter (Sep 24, 2015)
- K152409: Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC (Sep 24, 2015)
- K150407: BioFlo Midline Catheter (May 15, 2015)
- K150527: Xcela Power Injectable PICC (Mar 31, 2015)

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