510(k) Report

FDA applicant

Navilyst Medical, Inc.

Marlborough, MA35 decisions2009–201797 recalls

FDA records 35 decisions for Navilyst Medical, Inc. (Marlborough, MA) from 2009 to 2017: 35 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and FGE (Stents, Drains And Dilators For The Biliary…). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 80 predicates, 45 of them its own earlier devices. 97 recalls are linked to its devices, 2 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Navilyst Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2009: 32010: 22011: 52012: 52013: 72014: 42015: 62016: 22017: 1
2009high 7 (2013) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2026

2010: 12011: 22013: 12014: 122016: 182018: 402019: 52024: 162026 (partial year): 2, 2 Class I
2009high 40 (2018) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Navilyst Medical, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Navilyst Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days16decisions
  • FGEStents, Drains And Dilators For The Biliary Ducts4decisions
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular4decisions
  • DQOCatheter, Intravascular, Diagnostic3decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions
  • DREDilator, Vessel, For Percutaneous Catheterization2decisions

Also: DXT (1), MSD (1), FMF (1), DTL (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 63 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 101 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 80 predicates; 45 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 55 times; 45 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K121089Nmi Picc IiiNavilyst Medical, Inc. · 20126cite it
  • K093366Nmi Picc IINavilyst Medical, Inc. · 20095cite it
  • K091261Nmi PiccNavilyst Medical, Inc. · 20095cite it
  • K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 20114cite it
  • K101326NMI ICNavilyst Medical, Inc. · 20103cite it
  • K140266Nmi Picc IVNavilyst Medical, Inc. · 20143cite it

What has FDA decided for it lately?

  • K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 20175 recalls
  • K161866BioFlo Midline CatheterNavilyst Medical, Inc. · 20163 recalls
  • K151239Nmi Dual Port IINavilyst Medical, Inc. · 2016
  • K153228NMI Port, NMI Port IINavilyst Medical, Inc. · 2015
  • K152069Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe…Navilyst Medical, Inc. · 2015
  • K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc. · 20156 recalls
  • K150407BioFlo Midline CatheterNavilyst Medical, Inc. · 2015
  • K150527Xcela Power Injectable PICCNavilyst Medical, Inc. · 2015

All 35 as Navilyst Medical, Inc. →

What has been recalled?

97 recalls linked to its devices; the latest:

  • K113198NAMIC Angiographic Control Syringe, labeled as follows: 1.…Feb 27, 2026Class I
  • K131260BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU…Feb 13, 2026Class I
  • K131260BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in…Mar 18, 2024Class II
  • K132713MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous…Jan 30, 2024Class II
  • K132713MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous…Jan 30, 2024Class II
  • K132713MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous…Jan 30, 2024Class II