510(k) Report

FDA applicant

Fasstech

Burlington, MA9 decisions1993–20070 recalls

FDA records 9 decisions for Fasstech (Burlington, MA) from 1993 to 2007: 9 510(k) clearances. Most are in product codes HCC (Device, Biofeedback) and IKN (Electromyograph, Diagnostic). Its devices cite 9 predicates, 5 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, neurology panel, where it files most

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

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fasstech’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?

  • HCCDevice, Biofeedback5decisions
  • IKNElectromyograph, Diagnostic3decisions
  • KQXGoniometer, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 9 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K023209Insight Millennium IiiFasstech · 20033cite it
  • K990778Insight MillenniumFasstech · 19992cite it
  • K063447Insight DiscoveryFasstech · 20071cites it
  • K011964Insight Millennium PlusFasstech · 20011cites it

What has FDA decided for it lately?

  • K063447Insight DiscoveryFasstech · 2007
  • K033452CWAS 1000Fasstech · 2003
  • K023209Insight Millennium IiiFasstech · 2003
  • K011964Insight Millennium PlusFasstech · 2001
  • K011983Insight GenesisFasstech · 2001
  • K990778Insight MillenniumFasstech · 1999
  • K961212Spinal TouchFasstech · 1996
  • K940050Focus EmgFasstech · 1995

All 9 as Fasstech →