510(k) Report

FDA applicant

Teratech Corp.

Burlington, MA19 decisions1999–20200 recalls

FDA records 19 decisions for Teratech Corp. (Burlington, MA) from 1999 to 2020: 19 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 37 predicates, 20 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Teratech Corporation”.

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

FDA decisions per year

2in 2020

2008: 12011: 22012: 12013: 12014: 32015: 22020: 2
2007high 3 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Teratech 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?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic13decisions
  • ITXTransducer, Ultrasonic, Diagnostic4decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions

Whose devices does it build on?

Its devices cite 37 predicates; 20 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 37 times; 20 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.

  • K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp. · 20127cite it
  • K043278Teratech Model 8IOC4, 8IOL4 & 10LAP4 ProbesTeratech Corp. · 20044cite it
  • K110020Terason T3200 Ultrasound SystemTeratech Corp. · 20114cite it
  • K030191Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 20033cite it
  • K080234Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp. · 20083cite it
  • K992505Teratech, Model 2000 Imaging ImagingTeratech Corp. · 19992cite it

What has FDA decided for it lately?

  • K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation · 2020
  • K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation · 2020
  • K150533Terason uSmart3200T Ultrasound SystemTeratech Corp. · 2015
  • K150148Terason uSmart3300 Ultrasound SystemTeratech Corp. · 2015
  • K140773Terason USMART3300 Ultrasound SystemTeratech Corp. · 2014
  • K140834Terason USMART3400 Ultrasound SystemTeratech Corp. · 2014
  • K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp. · 2014
  • K131209Terason USMART3200T Ultrasound SystemTeratech Corp. · 2013

All 17 as Teratech Corp. →All 2 as Teratech Corporation →