FDA applicant

Hemo Sapiens, Inc.

Irvine, CA2 decisions1996–19970 recalls

FDA records 2 decisions for Hemo Sapiens, Inc. (Irvine, CA) from 1996 to 1997: 2 510(k) clearances. Most are in product codes DSB (Plethysmograph, Impedance) and DXG (Computer, Diagnostic, Pre-Programmed…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Hemo Sapiens, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Hemo”

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

Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger 1 Hemo-Barrier Technologies, Inc. 1

Hemo Sapiens, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Hemo”