Tray, Blood Sampling (Pulsator II)

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K760086 ↗

FDA Product Code

GJE

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Prefilled Pulsator Syringe

  Class II

  FDA 510(k) K811009 Active Cleared 12 Jun 1981

• Epidural Trays

  Class II

  FDA 510(k) K842095 Active Cleared 3 Jul 1984

• Syringe, Blood Sampling, Arterial, #4015

  Class II

  FDA 510(k) K770852 Active Cleared 14 Jul 1977

• Arterial Blood Sampling Kits

  Class I

  FDA 510(k) K841486 Active Cleared 23 May 1984

• Sani Catch Ba

  Class I

  FDA 510(k) K833814 Active Cleared 19 Mar 1984

• Tray, Catheterization W/ Catheter

  Class II

  FDA 510(k) K760128 Active Cleared 7 Oct 1976

See all devices from Concord Laboratories, Inc. →

• What clinical workflows is this blood sampling tray designed to support in a laboratory setting?

  The Tray, Blood Sampling (Pulsator II) is specifically designed for clinical chemistry and hematology applications. It organizes blood samples systematically to streamline workflows in these areas, ensuring specimens are handled efficiently for laboratory analysis.

• Is this tray intended for single-use or reusable applications, and how does that affect its maintenance?

  This tray is explicitly described as a reusable device, meaning it is meant to be cleaned and reused in clinical settings. Since it is not single-use, proper decontamination and maintenance protocols must be followed to ensure sterility and functionality between uses.

• What regulatory pathway was followed for FDA clearance, and what does that mean for its compliance?

  The Tray, Blood Sampling (Pulsator II) received FDA clearance under the Traditional 510(k) Review pathway (K760086) and is classified as Class II. This means it was determined to be substantially equivalent to a legally marketed device and must comply with 21 CFR 862.1675, which governs blood specimen handling in clinical chemistry workflows.

• Does this tray come in multiple sizes or models, and if so, how are they differentiated?

  The data provided includes multiple FEI numbers (1928237; 1000111918; 2648727; 3000717925; 3005012805), which typically indicate different models or variations of the same device. While exact size or model specifications are not detailed, these identifiers suggest the tray may be available in different configurations to accommodate varying laboratory needs.