V2 INJECTION SITE— 510(k) K955585

Clearance details

Applicant

B.Braun Medical, Inc.

Product code

Code FPA

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

1995-12-07

Decision date

1996-05-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bethlehem, PA, US

• K254123 — Ecomed Disposable Administration Sets2026-09-11
• K261530 — iiSure Infusion Set2026-06-03
• K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)2026-05-04
• K251375 — PuraCath Firefly Needleless Connector IT (9005)2026-02-12
• K251257 — nSet+ Stabilization Set [6426733] +2 more2025-12-04

• K254111 — Irrigation/Urology Sets2026-09-10
• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15
• K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets2025-07-24
• K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System2024-07-31
• K241845 — Introcan Safety® 2 IV Catheter2024-07-26

Death

95

Injury

14,421

Malfunction

125,815

Other

30

Total

140,361

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 →

• Z-0714-2026 — ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 2 ULTRASITE VLV, 104 IN; Catalog Number: 352049-C. 2. IV ADMIN SET W/ 3 ULTRASITE VLV, 112 IN; Catalog Number: 375100-C.Class II·Ongoing·B Braun Medical Inc·20251029
• Z-0090-2023 — ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension SetsClass II·Ongoing·B. Braun Medical, Inc.·20220915
• Z-0987-2014 — SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.Class II·Terminated·B. Braun Medical, Inc.·20140108
• Z-2166-2013 — Outlook Safety Infusion System Burette Set. For intravenous fluid administration.Class II·Terminated·B. Braun Medical, Inc.·20130805

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955585.