510(k) Report

FDA applicant

Checkpoint Surgical

Independence, OH1 decision2021–20212 recalls

FDA records 1 decision for Checkpoint Surgical (Independence, OH) in 2021: 1 510(k) clearance. All are in product code ETN (Stimulator, Nerve). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

2in 2025

2025: 2
2021high 2 (2025) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Checkpoint Surgical by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ETNStimulator, Nerve1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, LargeCheckpoint Surgical · 20212 recalls

The one decision as Checkpoint Surgical →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K212355Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian…Feb 24, 2025Class II
  • K212355Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian…Feb 24, 2025Class II