510(k) Report

FDA applicant

Kepler Medtec

Ashland, MA2 decisions2010–20110 recalls

FDA records 2 decisions for Kepler Medtec (Ashland, MA) from 2010 to 2011: 2 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and DSA (Cable, Transducer And Electrode, Patient…). Its devices cite 3 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2011

2010: 12011: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Kepler Medtec by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K101660Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8Kepler Medtec · 20102cite it
  • K110462Kepler Medtec Disposable Bipolar CableKepler Medtec · 20111cites it

What has FDA decided for it lately?

  • K110462Kepler Medtec Disposable Bipolar CableKepler Medtec · 2011
  • K101660Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8Kepler Medtec · 2010

All 2 as Kepler Medtec →