Suru Infusion Set Type J

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

510(k) Number

K802169 ↗

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 Blood Collection Set

  Class II

  FDA 510(k) K802170 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 is the Suru Infusion Set Type J used for?

  The Suru Infusion Set Type J is a sterile intravenous fluid infusion set designed for medical use to deliver fluids to patients intravenously. It features a bacteria retentive air inlet with snap-on cap and DEHP Free PVC tubing.

• Is the Suru Infusion Set Type J reusable or single-use?

  The Suru Infusion Set Type J is supplied sterile and is intended for single-use only. It should not be reused on multiple patients as this could compromise sterility and patient safety.

• What are the specifications of the Suru Infusion Set Type J?

  This infusion set has standard tube length of 150 cm with tube dimensions of 3.0 x 4.1 mm. It features DEHP Free PVC tubing with approximately 20 drops/mL and is available with or without airvent configuration.

• What regulatory clearance does the Suru Infusion Set Type J have?

  The Suru Infusion Set Type J received FDA 510(k) clearance with number K802169. It was determined to be substantially equivalent to other legally marketed devices.