# K954123: Low Profile Safsite Y-Site

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Nov 21, 1995 after 81 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K942988: Filtered Extension Sets, B. Braun of America, Inc. (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0605-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Sep 15, 2022 · Class II · Z-0091-2023: The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk
- Jan 8, 2014 · Class II · Z-0987-2014: Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle fre
- Nov 24, 2009 · Not classified · Z-0704-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0705-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi

## Indications for use
The component is used to provide needle-free access of IV sets and Extension Sets.

Source page: https://510kreport.com/device/K954123
Methodology: https://510kreport.com/methodology