510(k) Report

FDA applicant

Metritrack, Inc.

Hillside, IL2 decisions2014–20210 recalls

FDA records 2 decisions for Metritrack, Inc. (Hillside, IL) from 2014 to 2021: 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, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Metritrack, LLC”.

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 Metritrack, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014: 12021: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Metritrack, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Metritrack, 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; 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.

  • K141870Breast Volume NavigatorMetritrack, LLC · 20142cite it

What has FDA decided for it lately?

  • K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc. · 2021
  • K141870Breast Volume NavigatorMetritrack, LLC · 2014

The one decision as Metritrack, Inc. →The one decision as Metritrack, LLC →