FDA applicant

Fresenius Hemotechnology, Inc.

Concord, CA3 decisions1999–20011 recall

FDA records 3 decisions for Fresenius Hemotechnology, Inc. (Concord, CA) from 1999 to 2001: 3 510(k) clearances. Most are in product codes CAC (Apparatus, Autotransfusion) and DTN (Reservoir, Blood, Cardiopulmonary Bypass). Its devices cite 3 predicates, 0 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Fresenius Hemotechnology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fresenius Hemotechnology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Fresenius”

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

Fresenius Medical Care Renal Therapies Group, LLC 53 Fresenius Medical Care North America 43 Fresenius USA, Inc. 38 Fresenius Kabi AG 14 Fresenius Medical Care 7 Fresenius Medical Care North America, Design Cente 5 Fresenius Pharma 3 Fresenius AG 2 Fresenius Medical Care South Asia Pacific Pty, Ltd. 2 Fresenius Kabi USA,Llc 2 Fresenius/Delmed, Inc. 2 Fresenius Hemocare, Inc. 1

Fresenius Hemotechnology, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Fresenius”