510(k) Report

FDA applicant

The Surgical Company International B.V.

Beeldschermweg 6g, NL3 decisions2010–20251 recall

FDA records 3 decisions for The Surgical Company International B.V. (Beeldschermweg 6g, NL) from 2010 to 2025: 3 510(k) clearances. Most are in product codes LGZ (Warmer, Thermal, Infusion Fluid) and DWJ (System, Thermal Regulating). Its devices cite 6 predicates, 1 of them its own earlier devices. 1 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 hospital panel, where it files most

How often FDA has decided The Surgical Company International B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2010: 12023: 12025: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2010high 1 (2017) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — The Surgical Company International B.V. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like The Surgical Company International B.V.’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?

  • LGZWarmer, Thermal, Infusion Fluid2decisions
  • DWJSystem, Thermal Regulating1decision

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 2 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.

  • K101705Mistral-Air Warming SystemThe Surgical Company International B.V. · 20101cites it
  • K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. · 20231cites it

What has FDA decided for it lately?

  • K252636Fluido Compact SystemThe Surgical Company International B.V. · 2025
  • K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. · 2023
  • K101705Mistral-Air Warming SystemThe Surgical Company International B.V. · 20101 recall

All 3 as The Surgical Company International B.V. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K101705MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG…Jul 21, 2017Class II