510(k) Report

FDA applicant

Am USA

Nashville, TN4 decisions2011–20146 recalls

FDA records 4 decisions for Am USA (Nashville, TN) from 2011 to 2014: 4 510(k) clearances. All are in product code NGT (Saline, Vascular Access Flush). Its devices cite 4 predicates, 3 of them its own earlier devices. 6 recalls are linked to its devices.

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 Am USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12012: 22014: 1
2011high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2023

2012: 22015: 32023: 1
2011high 3 (2015) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Am USA by year, 2011–2026Sources: 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 Flush4decisions

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K111034AM Usa 0.9% Sodium Chloride Flush SyringeAm USA · 20113cite it
  • K1208360.9% Sodium Chloride Flish SyringeAm USA · 20121cites it
  • K1336850.9% Sodium Chloride Flush SyringeAm USA · 20141cites it

What has FDA decided for it lately?

  • K1336850.9% Sodium Chloride Flush SyringeAm USA · 20141 recall
  • K1208360.9% Sodium Chloride Flish SyringeAm USA · 20122 recalls
  • K113555AM Usa 0.9% Sodium Chloride Flush SyringeAm USA · 20121 recall
  • K111034AM Usa 0.9% Sodium Chloride Flush SyringeAm USA · 20112 recalls

All 4 as Am USA →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K113555AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF…Dec 28, 2023Class II
  • K1208360.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.Jul 2, 2015Class II
  • K1336850.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only…Apr 27, 2015Class II
  • K120836T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12…Feb 9, 2015Class II
  • K1110340.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single…Aug 15, 2012Class III
  • K1110340.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use…Aug 15, 2012Class III