510(k) Report

FDA applicant

EchoNous, Inc.

Redmond, WA5 decisions2018–20251 recall

FDA records 5 decisions for EchoNous, Inc. (Redmond, WA) from 2018 to 2025: 5 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 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 EchoNous, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12020: 12021: 12024: 12025: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2018high 1 (2024) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — EchoNous, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like EchoNous, 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?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic4decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 98 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 105 days; 2 of its 5 were faster than that.

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.

  • K193518KosmosEchoNous, Inc. · 20201cites it
  • K233826KosmosEchoNous, Inc. · 20241cites it

What has FDA decided for it lately?

  • K242321KosmosEchoNous, Inc. · 2025
  • K233826KosmosEchoNous, Inc. · 2024
  • K212100KosmosEchoNous, Inc. · 20211 recall
  • K193518KosmosEchoNous, Inc. · 2020
  • K181574UscanEchoNous, Inc. · 2018

All 5 as EchoNous, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K212100Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a…May 9, 2024Class II