510(k) Report

FDA applicant

Katalyst, Inc.

Seattle, WA3 decisions2017–20200 recalls

FDA records 3 decisions for Katalyst, Inc. (Seattle, WA) from 2017 to 2020: 3 510(k) clearances. All are in product code NGX (Stimulator, Muscle, Powered, For Muscle…). Since 2016 its 510(k)s took a median of 153 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 5 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2020

2017: 12018: 12020: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Katalyst, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Katalyst, Inc.’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?

  • NGXStimulator, Muscle, Powered, For Muscle Conditioning3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 153 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 108 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 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.

  • K190966Katalyst Training SystemKatalyst, Inc. · 20203cite it
  • K181199Katalyst Mark 1 Muscle Stimulation System Model 2Katalyst, Inc. · 20181cites it

What has FDA decided for it lately?

  • K190966Katalyst Training SystemKatalyst, Inc. · 2020
  • K181199Katalyst Mark 1 Muscle Stimulation System Model 2Katalyst, Inc. · 2018
  • K171035Katalyst Mark 1 Muscle Stimulation SystemKatalyst, Inc. · 2017

All 3 as Katalyst, Inc. →

Other applicant names beginning “Katalyst”

FDA records each applicant name separately; these may or may not be the same firm.

Katalyst Surgical, LLC 7