Context Filter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K791108 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hemastain Wright Stain

  Not classified

  FDA 510(k) K760486 Active Cleared 30 Aug 1976

• Hemastain Fixative

  Class I

  FDA 510(k) K760485 Active Cleared 30 Aug 1976

• Blood-Smearing Instrument (Miniprep Tm)

  Class I

  FDA 510(k) K760007 Active Cleared 3 Sep 1976

• Hematrak Model 480

  Class II

  FDA 510(k) K790816 Active Cleared 17 Jul 1979

• Hematrak

  Class II

  FDA 510(k) K770680 Active Cleared 1 Jul 1977

• Hematrak Rbc Morphology

  Class II

  FDA 510(k) K761207 Active Cleared 18 Oct 1977

See all devices from Geometric Data, Div. Smithkline Corp. →

• What is the Context Filter used for in clinical settings?

  The Context Filter is a Differential Cell Counter designed to automate the separation and quantification of white blood cells by size and density. It distinguishes between neutrophils, lymphocytes, monocytes, eosinophils, and basophils, streamlining diagnostic evaluations in hematology labs. This eliminates the need for manual differential counting, improving efficiency and accuracy.

• Is the Context Filter a single-use or reusable device?

  The Context Filter is supplied as a reusable instrument. It is intended for repeated use in clinical laboratories and hematology settings, provided it is maintained and stored according to the manufacturer’s guidelines to ensure consistent performance and sterility of blood samples.

• What type of blood samples does the Context Filter require?

  The Context Filter requires sterile blood samples for operation. Sterility is critical to prevent contamination and ensure accurate cell classification, as the device relies on physical filtration principles to analyze the sample without manual intervention.

• Does the Context Filter have any special storage or maintenance requirements?

  The Context Filter must be stored in accordance with the manufacturer’s guidelines to maintain its performance. While the device itself is reusable, proper storage conditions—such as cleanliness, protection from physical damage, and adherence to environmental controls—are essential to preserve functionality over time.

• Is the Context Filter compatible with MRI environments?

  No, the Context Filter is explicitly stated as not MRI-compatible. If used in proximity to MRI machines, the device should be positioned outside the MRI scan area to avoid potential interference or safety risks.