510(k) Report

FDA applicant

Tetrad Corp.

Englewood, CO4 decisions2001–20041 recall

FDA records 4 decisions for Tetrad Corp. (Englewood, CO) from 2001 to 2004: 4 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 3 predicates, 0 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Tetrad Corp. since 2007.

Recalls per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Tetrad Corp.’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?

  • ITXTransducer, Ultrasonic, Diagnostic3decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K013849Tetrad Model TC-EC7-Acp, -L5-, -L7-, -V4-Acp TransducersTetrad Corp. · 20011cites it

What has FDA decided for it lately?

  • K042620Sonata 3-D Imaging Accessory, Model 3DSTetrad Corp. · 2004
  • K014182Tetrad Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-Atp TransducersTetrad Corp. · 20021 recall
  • K013849Tetrad Model TC-EC7-Acp, -L5-, -L7-, -V4-Acp TransducersTetrad Corp. · 2001
  • K002193Tetrad TC-C3-AcpTetrad Corp. · 2001

All 4 as Tetrad Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K014182SCNHD LA L7-4 HDI Transducer ProbeJul 3, 2025Class III