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)
Top companies in DRS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2026 | Medline Industries, LP Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer Open, Classified |
DRS | K902472 |
| May 8, 2026 | Medline Industries, LP Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer Open, Classified |
DRS | K902472 |
| Mar 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield namic convenience kits labeled as:
KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160 Open, Classified |
DRS | K910764 |
| Jan 17, 2024 | Smiths Medical Asd Inc 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R Open, Classified |
DRS | K943897 |
| Jan 17, 2024 | Smiths Medical Asd Inc Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R Open, Classified |
DRS | K943897 |
| Jan 17, 2024 | Smiths Medical Asd Inc 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR Open, Classified |
DRS | K954970 |
| Jan 17, 2024 | Smiths Medical Asd Inc HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP Open, Classified |
DRS | K943897 |
| Jan 17, 2024 | Smiths Medical Asd Inc HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP Open, Classified |
DRS | K943897 |
| Jan 17, 2024 | Smiths Medical Asd Inc Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R Open, Classified |
DRS | K943897 |
| Jan 17, 2024 | Smiths Medical Asd Inc 6IN PRESSURE TUBING, List Number MX20617 Open, Classified |
DRS | K943897 |
| Jan 17, 2024 | Smiths Medical Asd Inc 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL Open, Classified |
DRS | K943897 |
| Jan 17, 2024 | Smiths Medical Asd Inc Medex LOGICAL CATH LAB KIT, List Number M20754 Open, Classified |
DRS | K820355 |
| Nov 29, 2023 | Edwards 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 |
DRS | K142749 K181684 +2 |
| Nov 29, 2023 | Edwards 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 |
DRS | K142749 K171996 +1 |
| Nov 29, 2023 | Edwards Lifesciences, LLC FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring. Open, Classified |
DRS | K152980 |
| Nov 29, 2023 | Edwards Lifesciences, LLC FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring. Open, Classified |
DRS | K152980 |
| Nov 29, 2023 | Edwards Lifesciences, LLC Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring. Open, Classified |
DRS | K152980 |
| Nov 29, 2023 | Edwards 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 |
DRS | K152980 |
| Apr 21, 2021 | Smiths Medical ASD Inc. Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer. Terminated |
DRS | None listed |
| Apr 21, 2021 | Smiths 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 |
DRS | None listed |
| Apr 21, 2021 | Smiths 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 |
DRS | None listed |
| Apr 21, 2021 | Smiths 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 |
DRS | None listed |
| Apr 21, 2021 | Smiths 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 |
DRS | K961404 |
| Apr 21, 2021 | Smiths 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 |
DRS | None listed |
| Apr 21, 2021 | Smiths Medical ASD Inc. LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring. Terminated |
DRS | K961404 |
| Apr 21, 2021 | Smiths Medical ASD Inc. Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling. Terminated |
DRS | K961404 |
| Apr 21, 2021 | Smiths Medical ASD Inc. LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling. Terminated |
DRS | K961404 |
| Nov 27, 2018 | ICU 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 |
DRS | K831506 |
| Nov 27, 2018 | ICU 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 |
DRS | K052828 |
| Nov 27, 2018 | ICU 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 |
DRS | None listed |
| Oct 16, 2018 | Argon 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 |
DRS | K810637 |
| Oct 16, 2018 | Argon 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 |
DRS | K820883 |
| Oct 16, 2018 | Argon 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 |
DRS | None listed |
| Oct 16, 2018 | Argon 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 |
DRS | K771701 |
| Oct 16, 2018 | Argon 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 |
DRS | K810637 |
| Oct 16, 2018 | Argon 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 |
DRS | K810637 |
| Oct 16, 2018 | Argon 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 |
DRS | K780271 |
| Oct 16, 2018 | Argon 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 |
DRS | K810637 |
| Oct 16, 2018 | Argon 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 |
DRS | K810637 |
| Nov 15, 2016 | ICU 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 |
DRS | K061573 |
| Nov 15, 2016 | ICU 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 |
DRS | K061573 |
| Nov 15, 2016 | ICU 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 |
DRS | K061573 |
| Nov 15, 2016 | ICU 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 |
DRS | K061573 |
| Nov 15, 2016 | ICU 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 |
DRS | None listed |
| Nov 15, 2016 | ICU 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 |
DRS | K061573 |
| Nov 15, 2016 | ICU 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 |
DRS | K061573 |
| Nov 15, 2016 | ICU 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 |
DRS | K061573 |
| Nov 15, 2016 | ICU 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 |
DRS | K061573 |
| Nov 15, 2016 | ICU 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 |
DRS | K061573 |
| Nov 15, 2016 | ICU 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 |
DRS | K061573 |
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