510(k) Report

FDA applicant

Tytan Medical Corp.

Hsin-Chu City, TW4 decisions2003–20100 recalls

FDA records 4 decisions for Tytan Medical Corp. (Hsin-Chu City, TW) from 2003 to 2010: 4 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DXQ (Blood Pressure Cuff). Its devices cite 4 predicates, 1 of them its own earlier devices. No 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tytan 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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • DXQBlood Pressure Cuff1decision
  • DQDStethoscope, Electronic1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K062238Tytan Blood Pressure CuffTytan Medical Corp. · 20061cites it
  • K033025Tytan Professional /Economy Series Sphygmomanometer, NO 710/NO 700Tytan Medical Corp. · 20031cites it

What has FDA decided for it lately?

  • K092893Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD Sphygmomanometer, Model A830…Tytan Medical Corp. · 2010
  • K062238Tytan Blood Pressure CuffTytan Medical Corp. · 2006
  • K033025Tytan Professional /Economy Series Sphygmomanometer, NO 710/NO 700Tytan Medical Corp. · 2003
  • K023637Tytan Electronic Stethoscopes (Model #600)Tytan Medical Corp. · 2003

All 4 as Tytan Medical Corp. →