510(k) Report

FDA applicant

Ecton, Inc.

Ambler, PA2 decisions1998–19990 recalls

FDA records 2 decisions for Ecton, Inc. (Ambler, PA) from 1998 to 1999: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 6 predicates, 0 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Ecton, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ecton, Inc.’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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K982800Ecton Lynx Ultrasound SystemEcton, Inc. · 19982cite it
  • K991872Lynx Ultrasound SystemEcton, Inc. · 19992cite it

What has FDA decided for it lately?

  • K991872Lynx Ultrasound SystemEcton, Inc. · 1999
  • K982800Ecton Lynx Ultrasound SystemEcton, Inc. · 1998

All 2 as Ecton, Inc. →