510(k) Report

FDA applicant

Sams, Inc.

Mchenry, IL1 decision1984–19843 recalls

FDA records 1 decision for Sams, Inc. (Mchenry, IL) in 1984: 1 510(k) clearance. All are in product code DWC (Controller, Temperature, Cardiopulmonary Bypass). 3 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Sams, Inc. since 2007.

Recalls per year

1in 2021

2016: 12018: 12021: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sams, 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?

  • DWCController, Temperature, Cardiopulmonary Bypass1decision

What has FDA decided for it lately?

  • K841402Temperature Control & MonitorSams, Inc. · 19843 recalls

The one decision as Sams, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K841402The Sarns Temperature Control and Monitor unit (TCM) is a source of…Apr 16, 2021Class II
  • K841402Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring…Mar 16, 2018Class II
  • K841402Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of…Jun 8, 2016Class II