510(k) Report

FDA applicant

Btl

Marlborough, MA4 decisions2019–20210 recalls

FDA records 4 decisions for Btl (Marlborough, MA) from 2019 to 2021: 4 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and NGX (Stimulator, Muscle, Powered, For Muscle…). Since 2016 its 510(k)s took a median of 225 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 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 Btl’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2019: 12020: 12021: 2
2019high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Btl by year, 2019–2026Sources: 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 & Accessories3decisions
  • NGXStimulator, Muscle, Powered, For Muscle Conditioning1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 225 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 126 days; 0 of its 4 were faster than that.

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 7 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.

What has FDA decided for it lately?

All 4 as Btl →