Suru Blood Collection Set

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

510(k) Number

K802170 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Scalp Vein Sets

  Class II

  FDA 510(k) K772008 Active Cleared 3 Jan 1978

• Solution Administration Set

  Class II

  FDA 510(k) K811006 Active Cleared 2 Jun 1981

• Suru Infusion Set Type J

  Class II

  FDA 510(k) K802169 Active Cleared 6 Apr 1981

• Sterile Blood Collection Set

  Class II

  FDA 510(k) K780657 Active Cleared 19 Jul 1978

• Sterile Blood Administration Set

  Class II

  FDA 510(k) K780658 Active Cleared 19 Jul 1978

• Sterile Infusion Set Type J

  Class II

  FDA 510(k) K780656 Active Cleared 19 Jul 1978

See all devices from Suru Chemicals & Pharmaceuticals, Ltd. →

• What types of settings can use the Suru Blood Collection Set, and why is it designed this way?

  The Suru Blood Collection Set is designed for use in hospital or blood bank settings, as it aligns with standard blood bank protocols and transfusion procedures. Its sterile, single-use construction ensures safety and reliability in controlled environments where aseptic techniques are critical, such as donor blood collection.

• Is the Suru Blood Collection Set reusable, or is it meant for one-time use? Why does this matter?

  The Suru Blood Collection Set is intended for single-use only. This design choice prevents contamination risks, maintains sterility, and ensures compliance with medical device safety standards, particularly important in blood collection where sterility is non-negotiable.

• What features does the Suru Blood Collection Set include to ensure proper handling during blood collection?

  The set includes donor tubing and a collection bag with hanger slits, which allow for secure suspension of the bag during blood collection. This design facilitates proper flow and stability, reducing the risk of spills or leaks while maintaining aseptic conditions.

• How should the Suru Blood Collection Set be stored, and why is this important?

  The set must be stored and handled following sterile medical device protocols to preserve its integrity. Since it is sterile and single-use, improper storage could compromise its cleanliness, potentially leading to contamination risks during blood collection.

• What regulatory pathway was used for FDA clearance, and what does this mean for its use?

  The Suru Blood Collection Set received FDA clearance under the Traditional 510(k) pathway, classified as substantially equivalent (SESE) to a predicate device. This means it was reviewed by the FDA’s General Hospital (HO) advisory committee and deemed safe and effective for its intended use in blood collection systems (product code FPA).