510(k) Report

FDA applicant

Barnstead/Thermolyne Corp.

Dubuque, IA2 decisions1997–20020 recalls

FDA records 2 decisions for Barnstead/Thermolyne Corp. (Dubuque, IA) from 1997 to 2002: 2 510(k) clearances. All are in product code FLE (Sterilizer, Steam). 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 hospital panel, where it files most

How often FDA has decided Barnstead/Thermolyne Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Barnstead/Thermolyne Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Barnstead/Thermolyne Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Barnstead/Thermolyne Corp.’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?

  • FLESterilizer, Steam2decisions

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 1 time; 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.

  • K953938SterilemaxBarnstead/Thermolyne Corp. · 19971cites it

What has FDA decided for it lately?

  • K014174Harvey PV Dry Sterilizer, Model # ST127325; ST127320; ST127320-33Barnstead/Thermolyne Corp. · 2002
  • K953938SterilemaxBarnstead/Thermolyne Corp. · 1997

All 2 as Barnstead/Thermolyne Corp. →