ClearanceBrief
Panels › Cardiovascular › Product code DRS · Class 2

Transducer, Blood-Pressure, Extravascular

Regulation 870.2850

1510(k)s in 12 months (149 all time)
2recalls in 12 months (236 all time)
226recalls that name a 510(k)
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Top companies in DRS

DateFirm and productCodeLinked 510(k)
May 8, 2026Medline Industries, LP
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Open, Classified
DRSK902472
May 8, 2026Medline Industries, LP
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
Open, Classified
DRSK902472
Mar 21, 2025MEDLINE INDUSTRIES, LP - Northfield
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Open, Classified
DRSK910764
Jan 17, 2024Smiths Medical Asd Inc
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Open, Classified
DRSK943897
Jan 17, 2024Smiths Medical Asd Inc
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
Open, Classified
DRSK943897
Jan 17, 2024Smiths Medical Asd Inc
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
Open, Classified
DRSK954970
Jan 17, 2024Smiths Medical Asd Inc
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
Open, Classified
DRSK943897
Jan 17, 2024Smiths Medical Asd Inc
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
Open, Classified
DRSK943897
Jan 17, 2024Smiths Medical Asd Inc
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
Open, Classified
DRSK943897
Jan 17, 2024Smiths Medical Asd Inc
6IN PRESSURE TUBING, List Number MX20617
Open, Classified
DRSK943897
Jan 17, 2024Smiths Medical Asd Inc
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Open, Classified
DRSK943897
Jan 17, 2024Smiths Medical Asd Inc
Medex LOGICAL CATH LAB KIT, List Number M20754
Open, Classified
DRSK820355
Nov 29, 2023Edwards Lifesciences, LLC
TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAM
Open, Classified
DRSK142749
K181684 +2
Nov 29, 2023Edwards Lifesciences, LLC
TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX
Open, Classified
DRSK142749
K171996 +1
Nov 29, 2023Edwards Lifesciences, LLC
FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.
Open, Classified
DRSK152980
Nov 29, 2023Edwards Lifesciences, LLC
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Open, Classified
DRSK152980
Nov 29, 2023Edwards Lifesciences, LLC
Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Open, Classified
DRSK152980
Nov 29, 2023Edwards Lifesciences, LLC
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
Open, Classified
DRSK152980
Apr 21, 2021Smiths Medical ASD Inc.
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
Terminated
DRSNone listed
Apr 21, 2021Smiths Medical ASD Inc.
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
Terminated
DRSNone listed
Apr 21, 2021Smiths Medical ASD Inc.
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
Terminated
DRSNone listed
Apr 21, 2021Smiths Medical ASD Inc.
HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
Terminated
DRSNone listed
Apr 21, 2021Smiths Medical ASD Inc.
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX
Terminated
DRSK961404
Apr 21, 2021Smiths Medical ASD Inc.
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN H
Terminated
DRSNone listed
Apr 21, 2021Smiths Medical ASD Inc.
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
Terminated
DRSK961404
Apr 21, 2021Smiths Medical ASD Inc.
Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
Terminated
DRSK961404
Apr 21, 2021Smiths Medical ASD Inc.
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Terminated
DRSK961404
Nov 27, 2018ICU Medical, Inc.
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
Terminated
DRSK831506
Nov 27, 2018ICU Medical, Inc.
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO
Terminated
DRSK052828
Nov 27, 2018ICU Medical, Inc.
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-0
Terminated
DRSNone listed
Oct 16, 2018Argon Medical Devices, Inc
Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Terminated
DRSK810637
Oct 16, 2018Argon Medical Devices, Inc
Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Terminated
DRSK820883
Oct 16, 2018Argon Medical Devices, Inc
Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medic
Terminated
DRSNone listed
Oct 16, 2018Argon Medical Devices, Inc
(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Rad
Terminated
DRSK771701
Oct 16, 2018Argon Medical Devices, Inc
Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Terminated
DRSK810637
Oct 16, 2018Argon Medical Devices, Inc
Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Terminated
DRSK810637
Oct 16, 2018Argon Medical Devices, Inc
(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, S
Terminated
DRSK780271
Oct 16, 2018Argon Medical Devices, Inc
Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Terminated
DRSK810637
Oct 16, 2018Argon Medical Devices, Inc
(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter,
Terminated
DRSK810637
Nov 15, 2016ICU Medical, Inc.
LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by conver
Terminated
DRSK061573
Nov 15, 2016ICU Medical, Inc.
CATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be
Terminated
DRSK061573
Nov 15, 2016ICU Medical, Inc.
Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and
Terminated
DRSK061573
Nov 15, 2016ICU Medical, Inc.
4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a ca
Terminated
DRSK061573
Nov 15, 2016ICU Medical, Inc.
Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac IV, Waste Bag System and 10 cc Control Syringe, Item No. 46300-11NS The Transpac Disposable Straight Pressure Transducer (DSPT) is a
Terminated
DRSNone listed
Nov 15, 2016ICU Medical, Inc.
Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac IV, 2 Admin Sets and 8 cc Control Syringe, Item No. 46300-01 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pre
Terminated
DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way Stopcocks and Admin Set, Item No. 46114-80 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extra
Terminated
DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patient Mount), Item No. 46114-24 The Transpac Disposable Straight Pressure Transducer
Terminated
DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No. 46113-91 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer th
Terminated
DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 46113-90 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrava
Terminated
DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush Device, Needleless Valves, Red, Blue and Yellow Stripe TBG, Item No. 46113-88 The Transpac Disposable Straight Pres
Terminated
DRSK061573

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