# K955585: V2 Injection Site

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: May 15, 1996 after 160 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 27 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942988 (1995). 1 ancestor in all.
45 later devices descend from it; 7 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942988: Filtered Extension Sets, B. Braun of America, Inc. (1995) Summary page 1.

## Most influential descendants
- K973167: Positive Pressure Connector (1997), 35 descendants of its own
- K031923: Ultrasite Valve (2003), 32 descendants of its own
- K083723: A6 Luer Access Device (2009), 31 descendants of its own
- K991653: Invision-Plus Injection Port Connector System (1999), 31 descendants of its own
- K021692: CLC2000 Catheter Patency Device (2003), 29 descendants of its own

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0714-2026: 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-0090-2023: 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
- Aug 5, 2013 · Class II · Z-2166-2013: Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corre
- Nov 24, 2009 · Not classified · Z-0685-2010: 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-0684-2010: 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-0686-2010: 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-0706-2010: 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-0708-2010: 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-0678-2010: 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-0707-2010: 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
- Mar 27, 2009 · Not classified · Z-1428-2009: Device defect is occlusion/no flow.
- Mar 27, 2009 · Not classified · Z-1427-2009: Device defect is occlusion/no flow.
- Mar 27, 2009 · Not classified · Z-1430-2009: Device defect is occlusion/no flow.
- Mar 27, 2009 · Not classified · Z-1429-2009: Device defect is occlusion/no flow.
- Mar 27, 2009 · Not classified · Z-1431-2009: Device defect is occlusion/no flow.
- Mar 27, 2009 · Not classified · Z-1433-2009: Device defect is occlusion/no flow.
- Mar 27, 2009 · Not classified · Z-1432-2009: Device defect is occlusion/no flow.
- Sep 17, 2008 · Not classified · Z-0199-2009: Product was assembled incorrectly and connected to the wrong part.
- Jun 30, 2008 · Not classified · Z-2410-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2407-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2411-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2413-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2412-2008: incorrect burette was packaged with the product
- Apr 18, 2007 · Not classified · Z-0818-2007: Secondary infusion backs up into primary container.
- Apr 18, 2007 · Not classified · Z-0819-2007: Secondary infusion backs up into primary container.
- Apr 14, 2003 · Not classified · Z-0933-03: possible leakage

## Indications for use
The V2 Injection Site is designed to provide needle-free access on I.V. and Extension Sets as an alternative to latex injection sites or other needle-free access systems.

Source page: https://510kreport.com/device/K955585
Methodology: https://510kreport.com/methodology