510(k) K955585 ยท FPA Set, Administration, Intravascular
V2 INJECTION SITE
| Applicant | B.Braun Medical, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, May 15, 1996 |
| Received | Dec 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B Braun Medical Inc 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 follow Open, Classified |
FPA | None listed |
| Oct 14, 2022 | B. Braun Medical, Inc. ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets Open, Classified |
FPA | None listed |
| Feb 18, 2014 | B. Braun Medical, Inc. 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 Terminated |
FPA | None listed |
| Sep 6, 2013 | B. Braun Medical, Inc. Outlook Safety Infusion System Burette Set.
For intravenous fluid administration. Terminated |
FRN | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 3 Ultrasite Inj Sites B/C Valve & Pressure Limited Check Valve 136 in US1500HP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, B/C Valve, 2 Ultrasite Inj Sites, 120 in US3121M Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock Con & Pressure, Limited Check Valve, 134 in US3140 Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, B/C Valve and Pressure Limited Check Valve, 124 in US1502HP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Safsite Inj Sites, Spin Lock Connector 134 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connector 132 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, 129 in Terminated |
FPA | None listed |
| Jun 5, 2009 | B. Braun Medical, Inc. IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin-Lock Connector, Catalog # 352049.
For use with Secondary Container. Terminated |
FPA | None listed |
| Jun 5, 2009 | B. Braun Medical, Inc. Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520.
For us Terminated |
FPA | None listed |
| Jun 5, 2009 | B. Braun Medical, Inc. Primary IV Set with Universal Spike, Backcheck Valve, 3 Ultrasite Injection Sites and Spin-Lock Connector, Catalog # 375100.
For use with Secondary Container. Terminated |
FPA | None listed |
| Jun 5, 2009 | B. Braun Medical, Inc. Ultrasite IV Administration Set with Universal Spike, three Backcheck Valves, three Ultrasite Injection Sites and Spin-Lock Connector, Catalog #470007.
For use with Secondary Container. Terminated |
FPA | None listed |
| Jun 5, 2009 | B. Braun Medical, Inc. Outlook Safety Infusion System IV Set with Universal Spike, Backcheck Valve, Ultrasite Injection Site and Spin-Lock Connector, Catalog #470046.
For use with the Horizon NXT Pump, and OutLook Safety I Terminated |
FPA | None listed |
| Jun 5, 2009 | B. Braun Medical, Inc. Anesthesia IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites, Injection Site, Ultraport High-Flow 4-Way Stopcock with Single Valve Port and Spin-Lock Connector, Catalog # 490 Terminated |
FPA | None listed |
| Jun 5, 2009 | B. Braun Medical, Inc. Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites and Spin-Lock Connector, Catalog # US3485.
For use with Secondary Container. Terminated |
FPA | None listed |
| Oct 24, 2008 | B. Braun Medical, Inc. Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton. Terminated |
FPA | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product i Terminated |
FRN | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlo Terminated |
FPA | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The product is shipped 20 units per carton. The product is for use afte Terminated |
FPA | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Add-On Burette Set with 150 ml burette and Ultrasite Injection Site without automatic shutoff. Item/Catalog number 375111. The product is shipped 20 units per carton. The product is for use after act Terminated |
FPA | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Add-On Burette Set with 150 ml burette 7 Ultrasite Injection Site with automatic shutoff, 20 in US1525M Metriset Add-on Burette Set. Item/Catalog number 375059. The product is shipped 20 units per car Terminated |
FPA | None listed |
| May 31, 2007 | B. Braun Medical, Inc. Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets. Terminated |
FPA | None listed |
| May 31, 2007 | B. Braun Medical, Inc. Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets. Terminated |
FPA | None listed |
| Jun 12, 2003 | Braun,B Medical Inc Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.