Filter Needle for Single Use— 510(k) K233277

Clearance details

Applicant

Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

Product code

Code FPB

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

2023-09-29

Decision date

2024-05-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hangzhou, CN

• K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter2026-08-31
• K143583 — Cathivex ¿GV filter units2015-08-11
• K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER2011-12-08
• K021293 — ARTERIA BLOOD FILTER2002-08-22
• K993379 — PALL SUPOR AEF FILTER1999-12-16

• K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)2026-08-07
• K260301 — Vial Adapter2026-06-05
• K233287 — Vent Vial Adapter2024-07-26
• K233284 — Vial Adapter with Filter2024-05-01
• K222718 — Vial Adapter2023-03-10

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →