510(k) Report

FDA applicant

Excelsior Medical Corp.

Neptune, NJ11 decisions1995–201421 recalls

FDA records 11 decisions for Excelsior Medical Corp. (Neptune, NJ) from 1995 to 2014: 11 510(k) clearances. Most are in product codes NGT (Saline, Vascular Access Flush) and NZW (Heparin, Vascular Access Flush). Its devices cite 11 predicates, 9 of them its own earlier devices. 21 recalls are linked to its devices.

FDA’s records also spell it “Excelsior Medical Corporation”.

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 Excelsior Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2007: 12008: 12009: 12011: 12013: 12014: 2
2007high 2 (2014) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2025

2009: 12010: 12012: 132016: 12018: 12022: 22025: 2
2007high 13 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Excelsior Medical Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NGTSaline, Vascular Access Flush3decisions
  • NZWHeparin, Vascular Access Flush3decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions
  • QBPCap, Device Disinfectant2decisions
  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 11 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 9 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.

  • K083508SwabcapExcelsior Medical Corp. · 20096cite it
  • K023740Syrex Pre-Filled SyringeExcelsior Medical Corp. · 20033cite it
  • K082837Sterile Field Saline Pre-Filled Syringe (S)Excelsior Medical Corp. · 20083cite it
  • K962938Excelsior Disposable Syringe W/Normal Saline (.9% Sodium Chloride)Excelsior Medical Corp. · 19962cite it
  • K130975Swabcap and SwabflushExcelsior Medical Corp. · 20132cite it
  • K053120Sterile Field Saline and Heparin Lock Flush SyringesExcelsior Medical Corp. · 20051cites it

What has FDA decided for it lately?

  • K1426200.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10…Excelsior Medical Corporation · 20141 recall
  • K133446Heparin Lock / Flush SyringesExcelsior Medical Corporation · 20141 recall
  • K130975Swabcap and SwabflushExcelsior Medical Corp. · 20132 recalls
  • K101270Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311Excelsior Medical Corp. · 2011
  • K083508SwabcapExcelsior Medical Corp. · 2009
  • K082837Sterile Field Saline Pre-Filled Syringe (S)Excelsior Medical Corp. · 20081 recall
  • K061497Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/MLExcelsior Medical Corp. · 200713 recalls
  • K053120Sterile Field Saline and Heparin Lock Flush SyringesExcelsior Medical Corp. · 20051 recall

All 9 as Excelsior Medical Corp. →All 2 as Excelsior Medical Corporation →

What has been recalled?

21 recalls linked to its devices; the latest:

  • K130975SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301Jun 16, 2025Class II
  • K130975SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000…Jun 3, 2025Class II
  • K133446Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled…May 25, 2022Class II
  • K082837Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection…Mar 4, 2022Class II
  • K142620Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for…Feb 1, 2018Class II
  • K023740Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL…Apr 28, 2016Class II

Other applicant names beginning “Excelsior”

FDA records each applicant name separately; these may or may not be the same firm.

Excelsior Resources, LLC 1