510(k) Report

FDA applicant

Halt Medical, Inc.

Brentwood, CA4 decisions2010–20140 recalls

FDA records 4 decisions for Halt Medical, Inc. (Brentwood, CA) from 2010 to 2014: 4 510(k) clearances. Most are in product codes HFG (Coagulator, Laparoscopic, Unipolar (And…) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 5 predicates, 2 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

2in 2014

2010: 12012: 12014: 2
2010high 2 (2014) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

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

Planning a device like Halt Medical, 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?

  • HFGCoagulator, Laparoscopic, Unipolar (And Accessories)3decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K121858The Ablation SystemHalt Medical, Inc. · 20123cite it
  • K094009Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GIHalt Medical, Inc. · 20101cites it
  • K132744Acessa Guidance SystemHalt Medical, Inc. · 20141cites it

What has FDA decided for it lately?

  • K132744Acessa Guidance SystemHalt Medical, Inc. · 2014
  • K132184Acessa Guidance HandpieceHalt Medical, Inc. · 2014
  • K121858The Ablation SystemHalt Medical, Inc. · 2012
  • K094009Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GIHalt Medical, Inc. · 2010

All 4 as Halt Medical, Inc. →