ClearanceBrief
510(k) K022895 ยท FMG Stopcock, I.V. Set

ELCAM STOPCOCKS AND MANIFOLDS

ApplicantMedical Device Consultants, Inc., North Attleboro MA, US
DecisionSubstantially Equivalent, Oct 18, 2002
ReceivedSep 3, 2002
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K022895

DateFirm and productCodeLinked 510(k)
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
FMGNone 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
FMGNone 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
FMGNone 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
FMGNone 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
FMGNone listed
Sep 13, 2024B. Braun Medical, Inc.
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
Open, Classified
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 490425
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid pathway; extension s
Terminated
FMGNone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrogenic fluid pathway;
Terminated
FMGNone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set and Minivolume Extension Set, product code 3C0108; An Rx sterile, nonpyrogenic f
Terminated
FMGNone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock Extension Set and Minivolume Extension Set, product code 3C0128; An Rx sterile, nonpyrogenic fluid pathway; solution set: 1
Terminated
FMGNone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set and Extension Set, product code 3C0172; An Rx sterile, nonpyrogenic fluid pathw
Terminated
FMGNone listed
Jun 30, 2005Baxter Healthcare Corp.
Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids;
Terminated
FMGNone listed

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