SAF-T Closed Blood Collection System with SAF-Holder Device, Model 99200

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

Full name

Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200, Saf-T Closed Blood Collection System with

510(k) Number

K072783 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Smiths Medical Asd, Inc. →

• What clinical setting is the SAF-T Closed Blood Collection System primarily designed for, and how does it differ from standard syringe blood draws?

  The SAF-T Closed Blood Collection System is designed specifically for clinical chemistry testing in clinical laboratory or point-of-care settings, particularly during peripheral IV catheter placement. Unlike standard syringe blood draws, it maintains a closed system to prevent contamination, reducing the risk of exposure to bloodborne pathogens. The integrated SAF-Holder Device stabilizes the syringe during transfer to vacuum tubes, minimizing leakage or spillage—critical for maintaining sample integrity and safety.

• Is this device reusable, or is it intended for single-use only? How does that affect its clinical workflow?

  This device is intended for single-use only, as explicitly stated in the product description. This design choice ensures sterility and reduces the risk of cross-contamination between patients. Clinically, this means each system must be discarded after a single procedure, requiring clinicians to prepare a new unit for each blood draw—though it streamlines workflow by eliminating cleaning or reprocessing steps.

• What sizes or models of the SAF-T system are available, and does the SAF-Holder Device come in multiple configurations?

  The data provided specifies one model number (99200) for the SAF-T Closed Blood Collection System with SAF-Holder Device, with no additional sizes or configurations mentioned. The SAF-Holder is integrated as a single component to stabilize the syringe during blood transfer, so no separate variants are referenced. Always verify the exact model and compatibility with your lab’s vacuum tubes before use.

• How should the SAF-T system be stored, and are there any special handling instructions for maintaining sterility?

  While the data doesn’t specify exact storage conditions, as a single-use medical device, it should be stored in its original, sealed packaging until use to preserve sterility. Avoid exposure to moisture, extreme temperatures, or direct sunlight. The closed-system design implies the components are sterile upon opening, so clinicians should handle it with standard aseptic technique—no additional sterilization is required before use.

• What was the regulatory pathway for FDA clearance of this device, and which advisory committee reviewed it?

  The SAF-T system received FDA clearance via the 510(k) pathway (K072783), determined to be substantially equivalent to a predicate device. The review was conducted by the Clinical Chemistry (CH) Advisory Committee, which evaluates blood collection and processing systems for laboratory diagnostics. This pathway confirms its compliance with U.S. regulations for closed blood collection systems used in clinical chemistry testing.