LOW PROFILE SAFSITE Y-SITE— 510(k) K954123

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

1995-09-01

Decision date

1995-11-21

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-0605-2026 — ADDitIV 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. PB602VSL NON-VENT SET 103-IN-DR; Catalog Number: 352062.Class II·Ongoing·B Braun Medical Inc·20251029
• Z-0091-2023 — Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.Class 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

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954123.