510(k) Report

FDA applicant

Tango3, LLC

Simpsonville, KY2 decisions2010–20151 recall

FDA records 2 decisions for Tango3, LLC (Simpsonville, KY) from 2010 to 2015: 2 510(k) clearances. All are in product code FIN (Tank, Holding, Dialysis). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Tango3, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2010: 12015: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2010high 1 (2012) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Tango3, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tango3, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FINTank, Holding, Dialysis2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K093641TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 20103cite it

What has FDA decided for it lately?

  • K140984TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015
  • K093641TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 20101 recall

All 2 as Tango3, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K093641TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens…Mar 26, 2012Class II