510(k) Report

FDA applicant

Sechrist

Anaheim, CA2 decisions1991–19931 recall

FDA records 2 decisions for Sechrist (Anaheim, CA) from 1991 to 1993: 2 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and LKD (Monitor, Carbon-Dioxide, Cutaneous). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Sechrist since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use1decision
  • LKDMonitor, Carbon-Dioxide, Cutaneous1decision

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.

  • K920121Sechrist IV-100B Savi SystemSechrist · 19931cites it

What has FDA decided for it lately?

  • K920121Sechrist IV-100B Savi SystemSechrist · 19931 recall
  • K905225Hbo Cable Assembly, Radiometer TC-02Sechrist · 1991

All 2 as Sechrist →

What has been recalled?

1 recall linked to its devices; the latest:

  • K811141Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.May 20, 2004

Other applicant names beginning “Sechrist”

FDA records each applicant name separately; these may or may not be the same firm.

Sechrist Industries, Inc. 23