ClearanceBrief
510(k) K942988 ยท FPA Set, Administration, Intravascular

FILTERED EXTENSION SETS

ApplicantB. Braun of America, Inc., Bethlehem PA, US
DecisionSubstantially Equivalent, Jul 14, 1995
ReceivedJun 20, 1994
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K942988

DateFirm and productCodeLinked 510(k)
Oct 16, 2026B Braun Medical Inc
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
Open, Classified
FPANone listed
Sep 2, 2026B Braun Medical Inc
Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Open, Classified
FPANone listed
Nov 26, 2025B 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
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
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
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
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
Jan 31, 2022B. 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
LHINone 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.
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
Mar 15, 2021B. 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
FPANone listed
Jul 9, 2014B. Braun Medical, Inc.
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Terminated
FPANone listed
Feb 18, 2014B. 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
FPANone listed
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure limited check valve 111 in V7412F
Terminated
FPANone listed
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 0.2um Filter, Pressure limited check valve 122 in V7415F
Terminated
FPANone listed
Jan 26, 2010B. 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
FPANone listed
Jan 26, 2010B. 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
FPANone listed
Jan 26, 2010B. 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
FPANone listed
Sep 23, 2008B. 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
FRNNone listed
Jun 12, 2003Braun,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
FPANone listed

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