Infusion Sets for Single Use with Needles

by Sichuan Prius Biotechnology Co., Ltd China 510(k)

510(k) K221069 Product code FPA

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK221069	Date21 Nov 2022Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K221069
FDA Product Code: FPA
FDA applicant: Sichuan Prius Biotechnology Co., Ltd.

Device Class: Class II
Regulation: 21 CFR Part 880.5440
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

Other devices from Sichuan Prius Biotechnology Co., Ltd

Sterile Hypodermic Syringes for Single Use with Safety Needles

Class II
Sterile Hypodermic Syringes for Single Use with Needles

Class II
Surgical Mask

Class II
Infusion sets for single use

Class IIa
Sterile hypodermic needles for single use

Class IIa
Sterile Safety hypodermic needles for single use

Class IIa

See all devices from Sichuan Prius Biotechnology Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K221069 24 fields · synced 22 Oct 2026