510(k) K942988 ยท FPA Set, Administration, Intravascular
FILTERED EXTENSION SETS
| Applicant | B. Braun of America, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Jul 14, 1995 |
| Received | Jun 20, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942988
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2026 | B Braun Medical Inc B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068. Open, Classified |
FPA | None listed |
| Sep 2, 2026 | B Braun Medical Inc Brand Name: Extension Set
Product Name: DISCOFIX FOUR WAY STOPCOCK
Model/Catalog Number: 456025 Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc 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 wi Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc Caresite 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 w Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc Extension 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 |
| Nov 26, 2025 | B Braun Medical Inc Extension 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 |
| Nov 26, 2025 | B Braun Medical Inc Extension 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 |
| Nov 26, 2025 | B Braun Medical Inc Extension 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 |
| Nov 26, 2025 | B Braun Medical Inc Extension 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 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration 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 th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV Administration 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 th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV Administration 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 th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV Administration 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 th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV Administration 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 th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV Administration 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 th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc Vista 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 Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc Outlook 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 followin Open, Classified |
FPA | None listed |
| Oct 14, 2022 | B. Braun Medical, Inc. 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 i Open, Classified |
FPA | None listed |
| Oct 14, 2022 | B. Braun Medical, Inc. CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood. Open, Classified |
FPA | None listed |
| Jan 31, 2022 | B. Braun Medical, Inc. Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500
Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dos Terminated |
LHI | None listed |
| Aug 10, 2021 | B. Braun Medical, Inc. Outlook Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 35421 Terminated |
FPA | None listed |
| Aug 10, 2021 | B. Braun Medical, Inc. OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 474004 Terminated |
FPA | None listed |
| Mar 15, 2021 | B. Braun Medical, Inc. Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermi Terminated |
FPA | None listed |
| Jul 9, 2014 | B. Braun Medical, Inc. STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches Terminated |
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 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure limited check valve 111 in V7412F Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 0.2um Filter, Pressure limited check valve 122 in V7415F Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um Filter, Pressure limited check valve 122 in SS3169F Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um Filter, Pressure limited check valve 122 in NF3169F Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj sites, 0.2um Filter, Pressure limited check valve 119 in US3169F Terminated |
FPA | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Saf Terminated |
FRN | 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.