ClearanceBrief
510(k) K083723 ยท FPA Set, Administration, Intravascular

A6 LUER ACCESS DEVICE

ApplicantB.Braun Medical, Inc., Allentown PA, US
DecisionSubstantially Equivalent, Jun 5, 2009
ReceivedDec 15, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K083723

DateFirm and productCodeLinked 510(k)
Nov 26, 2025B Braun Medical Inc
Anesthesia IV 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 fo
Open, Classified
FMGNone listed
Nov 26, 2025B Braun Medical Inc
Anesthesia IV 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 fo
Open, Classified
FPANone listed
Nov 26, 2025B Braun Medical Inc
Anesthesia IV 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 fo
Open, Classified
FPANone listed
Nov 26, 2025B Braun Medical Inc
Anesthesia IV 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 fo
Open, Classified
FPANone listed
Nov 26, 2025B Braun Medical Inc
Anesthesia IV 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 fo
Open, Classified
FPANone listed
Nov 26, 2025B Braun Medical Inc
B.BRAUN 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
FPANone listed
Nov 26, 2025B Braun Medical Inc
Blood 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
Open, Classified
FPANone listed
Nov 26, 2025B Braun Medical Inc
Blood 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
Open, Classified
FPANone listed
Nov 26, 2025B Braun Medical Inc
Blood 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
Open, Classified
FPANone listed
Nov 26, 2025B Braun Medical Inc
Burette 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Jul 17, 2024B. Braun Medical, Inc.
OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212
Open, Classified
FPANone listed
Jul 17, 2024B. Braun Medical, Inc.
OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354213
Open, Classified
FPANone listed
Oct 14, 2022B. 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
FPANone listed
Oct 14, 2022B. 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
FPANone listed
Aug 10, 2021B. Braun Medical, Inc.
15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
Terminated
FPANone listed
Aug 10, 2021B. Braun Medical, Inc.
Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
Terminated
FPANone listed
Aug 10, 2021B. 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
FPANone listed
Aug 10, 2021B. Braun Medical, Inc.
60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
Terminated
FPANone listed
Aug 10, 2021B. Braun Medical, Inc.
10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
Terminated
FPANone listed
Aug 10, 2021B. 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
FPANone listed
Aug 10, 2021B. Braun Medical, Inc.
OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
Terminated
FPANone listed
Nov 20, 2019B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490293
Terminated
FPANone listed
Nov 20, 2019B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490314
Terminated
FPANone listed
Nov 20, 2019B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490425
Terminated
FPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.